Study Assessing the Potential for Reduced Rates of Implant Failure Using Multi-Beam Intensity-Modulated Radiation Therapy for Locally Advanced Breast Cancer Patients With Implant Reconstructions

[
  {
    "op": "replace",
    "path": "/protocolSection/identificationModule/briefTitle",
    "value": "Study Assessing the Potential for Reduced Rates of Implant Failure Using Multi-Beam Intensity-Modulated Radiation Therapy for Locally Advanced Breast Cancer Patients With Implant Reconstructions"
  },
  {
    "op": "replace",
    "path": "/protocolSection/identificationModule/officialTitle",
    "value": "Phase II Study Assessing the Potential for Reduced Rates of Implant Failure Using Multi-Beam Intensity-Modulated Radiation Therapy for Locally Advanced Breast Cancer Patients With Implant Reconstructions"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2025-12-30"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2026-01-20"
  },
  {
    "op": "add",
    "path": "/protocolSection/statusModule/resultsFirstSubmitDate",
    "value": "2025-09-12"
  },
  {
    "op": "add",
    "path": "/protocolSection/statusModule/resultsFirstSubmitQcDate",
    "value": "2025-12-30"
  },
  {
    "op": "add",
    "path": "/protocolSection/statusModule/resultsFirstPostDateStruct",
    "value": {
      "date": "2026-01-20",
      "type": "ACTUAL"
    }
  },
  {
    "op": "remove",
    "path": "/protocolSection/oversightModule"
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  {
    "op": "replace",
    "path": "/protocolSection/designModule/designInfo/interventionModel",
    "value": "PARALLEL"
  },
  {
    "op": "replace",
    "path": "/protocolSection/designModule/enrollmentInfo/count",
    "value": 100
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/primaryOutcomes/0/measure",
    "value": "Incidence of Implant Failure"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/primaryOutcomes/0/description",
    "value": "The multi-beam IMRT would be considered efficacious if the incidence of implant failure is reduced by at least a relative 30% by the end of the study period (24 months post-IMRT for Group 1, and 30 months post-IMRT for Group 2)."
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
    "value": "24 months post-IMRT for Group 1, and 30 months post-IMRT for Group 2"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/0/measure",
    "value": "Incidence of Moderate to Severe Capsular Contracture"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/0/description",
    "value": "Will be examined using number of participants who developed Baker's grade <2 and ≥2 capsular contracture, respectively, at 12 or 18 months and 24 or 30 months after IMRT was administered.\nParticipants were assigned a Baker Classification score (a standardized 4-point scale, which integrates the texture and appearance of the breast) at baseline and each follow-up interval by the radiation oncologist or plastic surgeon (the higher of the 2 was used if the score was discordant).\nSignificant capsular contracture is measured as Baker grade III or IV."
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame",
    "value": "24 months post-IMRT for Group 1, and 30 months post-IMRT for Group 2"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/1/measure",
    "value": "Rates of Minor Revisional Surgeries"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/2/measure",
    "value": "Evaluate Cosmesis"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/2/description",
    "value": "To evaluate cosmesis, the Breast-Q© will be utilized in these assessments and will be presented descriptively, giving summary statistics for changes in the Breast-Q© scores over time.\nWith a focus on the post-operative period, the module will evaluate changes over time in four of the six subthemes identified by Breast-Q: (1) Psychosocial well-being; (2) Physical well-being; (3) Satisfaction with breasts; and (4) Satisfaction with outcome.\nEach subtheme will be evaluated using one or more scales.\nEach scale is independently scored into a value that ranges from 0 to 100, with higher score indicating greater satisfaction or better health-related quality of life."
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame",
    "value": "Baseline, Follow-up 1 (Arm 1:12 months (± 2 mo); Arm 2:12-18 months (± 6 mo)), Follow-up 2 (Arm 1:12-18 months (± 6 mo); Arm 2:18 months (± 2 mo)), and Follow-up 3 (Arm 1:24 months (± 2 mo); Arm 2:30 months (± 2 mo))"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/3/city",
    "value": "Harrison"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/3/geoPoint/lat",
    "value": 40.96899
  },
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    "path": "/protocolSection/contactsLocationsModule/locations/3/geoPoint/lon",
    "value": -73.71263
  },
  {
    "op": "remove",
    "path": "/annotationSection"
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    "path": "/hasResults",
    "value": true
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  {
    "op": "add",
    "path": "/resultsSection",
    "value": {
      "moreInfoModule": {
        "pointOfContact": {
          "email": "gelblumd@MSKCC.ORG",
          "phone": "914-367-7273",
          "title": "Dr. Daphna Gelblum, MD",
          "organization": "Memorial Sloan Kettering Cancer Center"
        },
        "certainAgreement": {
          "piSponsorEmployee": true
        }
      },
      "adverseEventsModule": {
        "timeFrame": "2 years",
        "eventGroups": [
          {
            "id": "EG000",
            "title": "IMRT to Temporary Expander",
            "description": "<p>Physical examination by MD, optional Breast MRI, Breast-Q© at baseline (after permanent implant exchange, physical exam and Breast-Q© may be done after the initiation of IMRT), 12 ± 2 months and 24 ± 2 months post- IMRT.\nTotal length of the follow-up time will be 24 ± 2 months post-IMRT.\nA subset of 10 left-sided patients will receive 13N-NH3 PET scans within the radiation simulation session.\nA CT for coronary calcium scoring and a low-dose CT for attenuation correction will also be obtained at this time.\nMyocardial blood flow will be measured during rest and at peak stress with 13N-NH3 as a perfusion tracer.\nA follow-up 13N-NH3 PET study with low-dose CT for attenuation correction will be obtained 12-18 months (± 6 months) post-IMRT.</p><p>Breast MRI</p><p>Breast-Q© questionnaire</p><p>Multi-Beam IMRT: The radiation dose (50-50.4\nGy&#x2F;25-28 fractions in approximately 5-6 weeks), treatment-planning and delivery aspects are according to departmental guidelines for breast IMRT.</p>",
            "otherNumAtRisk": 42,
            "deathsNumAtRisk": 42,
            "otherNumAffected": 32,
            "seriousNumAtRisk": 42,
            "deathsNumAffected": 0,
            "seriousNumAffected": 3
          },
          {
            "id": "EG001",
            "title": "IMRT to Permanent Implant",
            "description": "<p>Physical examination by MD, optional Breast MRI, Breast-Q © at baseline (after permanent implant exchange and after IMRT), 18 ± 2 months and 30 ± 2 months post-IMRT, as these patients will undergo exchange of the temporary expander for the permanent implant approximately 4-8 months following the completion of radiation (at the discretion of the treating plastic surgeon).\nTotal length of the follow-up time will be 30 ± 2 months post-IMRT</p><p>Breast MRI</p><p>Breast-Q© questionnaire</p><p>Multi-Beam IMRT: The radiation dose (50-50.4\nGy&#x2F;25-28 fractions in approximately 5-6 weeks), treatment-planning and delivery aspects are according to departmental guidelines for breast IMRT.</p>",
            "otherNumAtRisk": 58,
            "deathsNumAtRisk": 58,
            "otherNumAffected": 58,
            "seriousNumAtRisk": 58,
            "deathsNumAffected": 8,
            "seriousNumAffected": 15
          }
        ],
        "otherEvents": [
          {
            "term": "Alanine aminotransferase increased",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 42,
                "numAffected": 0
              },
              {
                "groupId": "EG001",
                "numAtRisk": 58,
                "numAffected": 1
              }
            ],
            "organSystem": "Investigations",
            "assessmentType": "SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "Anemia",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 42,
                "numAffected": 0
              },
              {
                "groupId": "EG001",
                "numAtRisk": 58,
                "numAffected": 6
              }
            ],
            "organSystem": "Blood and lymphatic system disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "Blood bilirubin increased",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 42,
                "numAffected": 0
              },
              {
                "groupId": "EG001",
                "numAtRisk": 58,
                "numAffected": 1
              }
            ],
            "organSystem": "Investigations",
            "assessmentType": "SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "Hyperglycemia",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 42,
                "numAffected": 0
              },
              {
                "groupId": "EG001",
                "numAtRisk": 58,
                "numAffected": 4
              }
            ],
            "organSystem": "Metabolism and nutrition disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "Hypoalbuminemia",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 42,
                "numAffected": 0
              },
              {
                "groupId": "EG001",
                "numAtRisk": 58,
                "numAffected": 1
              }
            ],
            "organSystem": "Metabolism and nutrition disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "Hypocalcemia",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 42,
                "numAffected": 0
              },
              {
                "groupId": "EG001",
                "numAtRisk": 58,
                "numAffected": 3
              }
            ],
            "organSystem": "Metabolism and nutrition disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "Hypokalemia",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 42,
                "numAffected": 0
              },
              {
                "groupId": "EG001",
                "numAtRisk": 58,
                "numAffected": 1
              }
            ],
            "organSystem": "Metabolism and nutrition disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "Hypomagnesemia",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 42,
                "numAffected": 0
              },
              {
                "groupId": "EG001",
                "numAtRisk": 58,
                "numAffected": 1
              }
            ],
            "organSystem": "Metabolism and nutrition disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "Hyponatremia",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 42,
                "numAffected": 0
              },
              {
                "groupId": "EG001",
                "numAtRisk": 58,
                "numAffected": 1
              }
            ],
            "organSystem": "Metabolism and nutrition disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "Hypophosphatemia",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 42,
                "numAffected": 0
              },
              {
                "groupId": "EG001",
                "numAtRisk": 58,
                "numAffected": 1
              }
            ],
            "organSystem": "Metabolism and nutrition disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "Lymphocyte count decreased",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 42,
                "numAffected": 23
              },
              {
                "groupId": "EG001",
                "numAtRisk": 58,
                "numAffected": 33
              }
            ],
            "organSystem": "Investigations",
            "assessmentType": "SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "Neutrophil count decreased",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 42,
                "numAffected": 2
              },
              {
                "groupId": "EG001",
                "numAtRisk": 58,
                "numAffected": 7
              }
            ],
            "organSystem": "Investigations",
            "assessmentType": "SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "Platelet count decreased",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 42,
                "numAffected": 0
              },
              {
                "groupId": "EG001",
                "numAtRisk": 58,
                "numAffected": 1
              }
            ],
            "organSystem": "Blood and lymphatic system disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "White blood cell decreased",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 42,
                "numAffected": 7
              },
              {
                "groupId": "EG001",
                "numAtRisk": 58,
                "numAffected": 16
              }
            ],
            "organSystem": "Investigations",
            "assessmentType": "SYSTEMATIC_ASSESSMENT"
          }
        ],
        "seriousEvents": [
          {
            "term": "Breast infection",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 42,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
                "numAtRisk": 58,
                "numAffected": 7
              }
            ],
            "organSystem": "Infections and infestations",
            "assessmentType": "SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "Breast pain",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 42,
                "numAffected": 0
              },
              {
                "groupId": "EG001",
                "numAtRisk": 58,
                "numAffected": 1
              }
            ],
            "organSystem": "Reproductive system and breast disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "Chest pain - cardiac",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 42,
                "numAffected": 0
              },
              {
                "groupId": "EG001",
                "numAtRisk": 58,
                "numAffected": 1
              }
            ],
            "organSystem": "Cardiac disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "Chest wall pain",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 42,
                "numAffected": 0
              },
              {
                "groupId": "EG001",
                "numAtRisk": 58,
                "numAffected": 1
              }
            ],
            "organSystem": "Musculoskeletal and connective tissue disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "Dyspnea",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 42,
                "numAffected": 0
              },
              {
                "groupId": "EG001",
                "numAtRisk": 58,
                "numAffected": 2
              }
            ],
            "organSystem": "Respiratory, thoracic and mediastinal disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "Gastrointestinal disorders - Other, specify",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 42,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
                "numAtRisk": 58,
                "numAffected": 0
              }
            ],
            "organSystem": "Gastrointestinal disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "Hypoxia",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 42,
                "numAffected": 0
              },
              {
                "groupId": "EG001",
                "numAtRisk": 58,
                "numAffected": 1
              }
            ],
            "organSystem": "Respiratory, thoracic and mediastinal disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "Infections and infestations - Other, specify",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 42,
                "numAffected": 0
              },
              {
                "groupId": "EG001",
                "numAtRisk": 58,
                "numAffected": 1
              }
            ],
            "organSystem": "Infections and infestations",
            "assessmentType": "SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "Nausea",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 42,
                "numAffected": 0
              },
              {
                "groupId": "EG001",
                "numAtRisk": 58,
                "numAffected": 1
              }
            ],
            "organSystem": "Gastrointestinal disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "Non-cardiac chest pain",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 42,
                "numAffected": 0
              },
              {
                "groupId": "EG001",
                "numAtRisk": 58,
                "numAffected": 1
              }
            ],
            "organSystem": "General disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "Pain in extremity",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 42,
                "numAffected": 0
              },
              {
                "groupId": "EG001",
                "numAtRisk": 58,
                "numAffected": 1
              }
            ],
            "organSystem": "Musculoskeletal and connective tissue disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "Pneumonitis",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 42,
                "numAffected": 0
              },
              {
                "groupId": "EG001",
                "numAtRisk": 58,
                "numAffected": 1
              }
            ],
            "organSystem": "Respiratory, thoracic and mediastinal disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "Skin infection",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 42,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
                "numAtRisk": 58,
                "numAffected": 0
              }
            ],
            "organSystem": "Infections and infestations",
            "assessmentType": "SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "Wound dehiscence",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 42,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
                "numAtRisk": 58,
                "numAffected": 1
              }
            ],
            "organSystem": "Injury, poisoning and procedural complications",
            "assessmentType": "SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "Wound infection",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 42,
                "numAffected": 0
              },
              {
                "groupId": "EG001",
                "numAtRisk": 58,
                "numAffected": 2
              }
            ],
            "organSystem": "Infections and infestations",
            "assessmentType": "SYSTEMATIC_ASSESSMENT"
          }
        ],
        "frequencyThreshold": "0"
      },
      "outcomeMeasuresModule": {
        "outcomeMeasures": [
          {
            "type": "PRIMARY",
            "title": "Incidence of Implant Failure",
            "denoms": [
              {
                "units": "Participants",
                "counts": [
                  {
                    "value": "42",
                    "groupId": "OG000"
                  },
                  {
                    "value": "58",
                    "groupId": "OG001"
                  }
                ]
              }
            ],
            "groups": [
              {
                "id": "OG000",
                "title": "IMRT to Temporary Expander",
                "description": "<p>Physical examination by MD, optional Breast MRI, Breast-Q© at baseline (after permanent implant exchange, physical exam and Breast-Q© may be done after the initiation of IMRT), 12 ± 2 months and 24 ± 2 months post- IMRT.\nTotal length of the follow-up time will be 24 ± 2 months post-IMRT.\nA subset of 10 left-sided patients will receive 13N-NH3 PET scans within the radiation simulation session.\nA CT for coronary calcium scoring and a low-dose CT for attenuation correction will also be obtained at this time.\nMyocardial blood flow will be measured during rest and at peak stress with 13N-NH3 as a perfusion tracer.\nA follow-up 13N-NH3 PET study with low-dose CT for attenuation correction will be obtained 12-18 months (± 6 months) post-IMRT.</p><p>Breast MRI</p><p>Breast-Q© questionnaire</p><p>Multi-Beam IMRT: The radiation dose (50-50.4\nGy&#x2F;25-28 fractions in approximately 5-6 weeks), treatment-planning and delivery aspects are according to departmental guidelines for breast IMRT.</p>"
              },
              {
                "id": "OG001",
                "title": "IMRT to Permanent Implant",
                "description": "<p>Physical examination by MD, optional Breast MRI, Breast-Q © at baseline (after permanent implant exchange and after IMRT), 18 ± 2 months and 30 ± 2 months post-IMRT, as these patients will undergo exchange of the temporary expander for the permanent implant approximately 4-8 months following the completion of radiation (at the discretion of the treating plastic surgeon).\nTotal length of the follow-up time will be 30 ± 2 months post-IMRT</p><p>Breast MRI</p><p>Breast-Q© questionnaire</p><p>Multi-Beam IMRT: The radiation dose (50-50.4\nGy&#x2F;25-28 fractions in approximately 5-6 weeks), treatment-planning and delivery aspects are according to departmental guidelines for breast IMRT.</p>"
              }
            ],
            "classes": [
              {
                "title": "Implant Failure",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "8",
                        "groupId": "OG000"
                      },
                      {
                        "value": "17",
                        "groupId": "OG001"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "No Implant Failure",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "34",
                        "groupId": "OG000"
                      },
                      {
                        "value": "41",
                        "groupId": "OG001"
                      }
                    ]
                  }
                ]
              }
            ],
            "paramType": "NUMBER",
            "timeFrame": "24 months post-IMRT for Group 1, and 30 months post-IMRT for Group 2",
            "description": "The multi-beam IMRT would be considered efficacious if the incidence of implant failure is reduced by at least a relative 30% by the end of the study period (24 months post-IMRT for Group 1, and 30 months post-IMRT for Group 2).",
            "unitOfMeasure": "Number of Participants with Implant Fail",
            "reportingStatus": "POSTED"
          },
          {
            "type": "SECONDARY",
            "title": "Incidence of Moderate to Severe Capsular Contracture",
            "denoms": [
              {
                "units": "Participants",
                "counts": [
                  {
                    "value": "42",
                    "groupId": "OG000"
                  },
                  {
                    "value": "58",
                    "groupId": "OG001"
                  }
                ]
              }
            ],
            "groups": [
              {
                "id": "OG000",
                "title": "IMRT to Temporary Expander",
                "description": "<p>Physical examination by MD, optional Breast MRI, Breast-Q© at baseline (after permanent implant exchange, physical exam and Breast-Q© may be done after the initiation of IMRT), 12 ± 2 months and 24 ± 2 months post- IMRT.\nTotal length of the follow-up time will be 24 ± 2 months post-IMRT.\nA subset of 10 left-sided patients will receive 13N-NH3 PET scans within the radiation simulation session.\nA CT for coronary calcium scoring and a low-dose CT for attenuation correction will also be obtained at this time.\nMyocardial blood flow will be measured during rest and at peak stress with 13N-NH3 as a perfusion tracer.\nA follow-up 13N-NH3 PET study with low-dose CT for attenuation correction will be obtained 12-18 months (± 6 months) post-IMRT.</p><p>Breast MRI</p><p>Breast-Q© questionnaire</p><p>Multi-Beam IMRT: The radiation dose (50-50.4\nGy&#x2F;25-28 fractions in approximately 5-6 weeks), treatment-planning and delivery aspects are according to departmental guidelines for breast IMRT.</p>"
              },
              {
                "id": "OG001",
                "title": "IMRT to Permanent Implant",
                "description": "<p>Physical examination by MD, optional Breast MRI, Breast-Q © at baseline (after permanent implant exchange and after IMRT), 18 ± 2 months and 30 ± 2 months post-IMRT, as these patients will undergo exchange of the temporary expander for the permanent implant approximately 4-8 months following the completion of radiation (at the discretion of the treating plastic surgeon).\nTotal length of the follow-up time will be 30 ± 2 months post-IMRT</p><p>Breast MRI</p><p>Breast-Q© questionnaire</p><p>Multi-Beam IMRT: The radiation dose (50-50.4\nGy&#x2F;25-28 fractions in approximately 5-6 weeks), treatment-planning and delivery aspects are according to departmental guidelines for breast IMRT.</p>"
              }
            ],
            "classes": [
              {
                "categories": [
                  {
                    "title": "Grade IA-II Capsular Contracture",
                    "measurements": [
                      {
                        "value": "26",
                        "groupId": "OG000"
                      },
                      {
                        "value": "36",
                        "groupId": "OG001"
                      }
                    ]
                  },
                  {
                    "title": "Grade III-IV Capsular Contracture",
                    "measurements": [
                      {
                        "value": "16",
                        "groupId": "OG000"
                      },
                      {
                        "value": "11",
                        "groupId": "OG001"
                      }
                    ]
                  },
                  {
                    "title": "No Capsular Contracture",
                    "measurements": [
                      {
                        "value": "0",
                        "groupId": "OG000"
                      },
                      {
                        "value": "11",
                        "groupId": "OG001"
                      }
                    ]
                  }
                ]
              }
            ],
            "paramType": "COUNT_OF_PARTICIPANTS",
            "timeFrame": "24 months post-IMRT for Group 1, and 30 months post-IMRT for Group 2",
            "description": "Will be examined using number of participants who developed Baker&#x27;s grade &lt;2 and ≥2 capsular contracture, respectively, at 12 or 18 months and 24 or 30 months after IMRT was administered.\nParticipants were assigned a Baker Classification score (a standardized 4-point scale, which integrates the texture and appearance of the breast) at baseline and each follow-up interval by the radiation oncologist or plastic surgeon (the higher of the 2 was used if the score was discordant).\nSignificant capsular contracture is measured as Baker grade III or IV.",
            "unitOfMeasure": "Participants",
            "reportingStatus": "POSTED"
          },
          {
            "type": "SECONDARY",
            "title": "Rates of Minor Revisional Surgeries",
            "denoms": [
              {
                "units": "Participants",
                "counts": [
                  {
                    "value": "42",
                    "groupId": "OG000"
                  },
                  {
                    "value": "58",
                    "groupId": "OG001"
                  }
                ]
              }
            ],
            "groups": [
              {
                "id": "OG000",
                "title": "IMRT to Temporary Expander",
                "description": "<p>Physical examination by MD, optional Breast MRI, Breast-Q© at baseline (after permanent implant exchange, physical exam and Breast-Q© may be done after the initiation of IMRT), 12 ± 2 months and 24 ± 2 months post- IMRT.\nTotal length of the follow-up time will be 24 ± 2 months post-IMRT.\nA subset of 10 left-sided patients will receive 13N-NH3 PET scans within the radiation simulation session.\nA CT for coronary calcium scoring and a low-dose CT for attenuation correction will also be obtained at this time.\nMyocardial blood flow will be measured during rest and at peak stress with 13N-NH3 as a perfusion tracer.\nA follow-up 13N-NH3 PET study with low-dose CT for attenuation correction will be obtained 12-18 months (± 6 months) post-IMRT.</p><p>Breast MRI</p><p>Breast-Q© questionnaire</p><p>Multi-Beam IMRT: The radiation dose (50-50.4\nGy&#x2F;25-28 fractions in approximately 5-6 weeks), treatment-planning and delivery aspects are according to departmental guidelines for breast IMRT.</p>"
              },
              {
                "id": "OG001",
                "title": "IMRT to Permanent Implant",
                "description": "<p>Physical examination by MD, optional Breast MRI, Breast-Q © at baseline (after permanent implant exchange and after IMRT), 18 ± 2 months and 30 ± 2 months post-IMRT, as these patients will undergo exchange of the temporary expander for the permanent implant approximately 4-8 months following the completion of radiation (at the discretion of the treating plastic surgeon).\nTotal length of the follow-up time will be 30 ± 2 months post-IMRT</p><p>Breast MRI</p><p>Breast-Q© questionnaire</p><p>Multi-Beam IMRT: The radiation dose (50-50.4\nGy&#x2F;25-28 fractions in approximately 5-6 weeks), treatment-planning and delivery aspects are according to departmental guidelines for breast IMRT.</p>"
              }
            ],
            "classes": [
              {
                "categories": [
                  {
                    "title": "Participants with minor surgical corrections",
                    "measurements": [
                      {
                        "value": "0",
                        "groupId": "OG000"
                      },
                      {
                        "value": "2",
                        "groupId": "OG001"
                      }
                    ]
                  },
                  {
                    "title": "Participants without minor surgical corrections",
                    "measurements": [
                      {
                        "value": "42",
                        "groupId": "OG000"
                      },
                      {
                        "value": "56",
                        "groupId": "OG001"
                      }
                    ]
                  }
                ]
              }
            ],
            "paramType": "COUNT_OF_PARTICIPANTS",
            "timeFrame": "2 years",
            "description": "Incidence of minor revisional surgeries by plastic surgeon will be evaluated by proportions too.\nAgain, the rates (proportions) will be compared across the two groups.",
            "unitOfMeasure": "Participants",
            "reportingStatus": "POSTED"
          },
          {
            "type": "SECONDARY",
            "title": "Evaluate Cosmesis",
            "denoms": [
              {
                "units": "Participants",
                "counts": [
                  {
                    "value": "42",
                    "groupId": "OG000"
                  },
                  {
                    "value": "58",
                    "groupId": "OG001"
                  }
                ]
              }
            ],
            "groups": [
              {
                "id": "OG000",
                "title": "Arm 1: IMRT to Temporary Expander",
                "description": "<p>Physical examination by MD, optional Breast MRI, Breast-Q© at baseline (after permanent implant exchange, physical exam and Breast-Q© may be done after the initiation of IMRT), 12 ± 2 months and 24 ± 2 months post- IMRT.\nTotal length of the follow-up time will be 24 ± 2 months post-IMRT.\nA subset of 10 left-sided patients will receive 13N-NH3 PET scans within the radiation simulation session.\nA CT for coronary calcium scoring and a low-dose CT for attenuation correction will also be obtained at this time.\nMyocardial blood flow will be measured during rest and at peak stress with 13N-NH3 as a perfusion tracer.\nA follow-up 13N-NH3 PET study with low-dose CT for attenuation correction will be obtained 12-18 months (± 6 months) post-IMRT.</p><p>Breast MRI</p><p>Breast-Q© questionnaire</p><p>Multi-Beam IMRT: The radiation dose (50-50.4\nGy&#x2F;25-28 fractions in approximately 5-6 weeks), treatment-planning and delivery aspects are according to departmental guidelines for breast IMRT.</p>"
              },
              {
                "id": "OG001",
                "title": "Arm 2: IMRT to Permanent Implant",
                "description": "<p>Physical examination by MD, optional Breast MRI, Breast-Q © at baseline (after permanent implant exchange and after IMRT), 18 ± 2 months and 30 ± 2 months post-IMRT, as these patients will undergo exchange of the temporary expander for the permanent implant approximately 4-8 months following the completion of radiation (at the discretion of the treating plastic surgeon).\nTotal length of the follow-up time will be 30 ± 2 months post-IMRT</p><p>Breast MRI</p><p>Breast-Q© questionnaire</p><p>Multi-Beam IMRT: The radiation dose (50-50.4\nGy&#x2F;25-28 fractions in approximately 5-6 weeks), treatment-planning and delivery aspects are according to departmental guidelines for breast IMRT.</p>"
              }
            ],
            "classes": [
              {
                "title": "Baseline Physical Well Being Abdomen",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "84",
                        "groupId": "OG000",
                        "lowerLimit": "76",
                        "upperLimit": "92"
                      },
                      {
                        "value": "64",
                        "groupId": "OG001",
                        "lowerLimit": "59",
                        "upperLimit": "92"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Follow-up 1 Physical Well Being Abdomen-Arm 1:12 months (± 2 mo); Arm 2:12-18 months (± 6 mo)",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "70",
                        "groupId": "OG000",
                        "lowerLimit": "53",
                        "upperLimit": "74"
                      },
                      {
                        "value": "59",
                        "groupId": "OG001",
                        "lowerLimit": "47",
                        "upperLimit": "70"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Follow-up 2 Physical Well Being Abdomen-Arm 1:12-18 months (± 6 mo); Arm 2:18 months (± 2 mo)",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "76",
                        "groupId": "OG000",
                        "lowerLimit": "62",
                        "upperLimit": "79"
                      },
                      {
                        "value": "69",
                        "groupId": "OG001",
                        "lowerLimit": "46",
                        "upperLimit": "82"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Follow-up 3 Physical Well Being Abdomen-Arm 1:24 months (± 2 mo); Arm 2:30 months (± 2 mo)",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "69",
                        "groupId": "OG000",
                        "lowerLimit": "45",
                        "upperLimit": "72"
                      },
                      {
                        "value": "50",
                        "groupId": "OG001",
                        "lowerLimit": "0",
                        "upperLimit": "75"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Baseline Physical Well Being Chest",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "68",
                        "groupId": "OG000",
                        "lowerLimit": "58",
                        "upperLimit": "83"
                      },
                      {
                        "value": "60",
                        "groupId": "OG001",
                        "lowerLimit": "55",
                        "upperLimit": "67"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Follow-up 1 Physical Well Being Chest-Arm 1:12 months (± 2 mo); Arm 2:12-18 months (± 6 mo)",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "61",
                        "groupId": "OG000",
                        "lowerLimit": "50",
                        "upperLimit": "74"
                      },
                      {
                        "value": "63",
                        "groupId": "OG001",
                        "lowerLimit": "53",
                        "upperLimit": "84"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Follow-up 2 Physical Well Being Chest-Arm 1:12-18 months (± 6 mo); Arm 2:18 months (± 2 mo)",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "66",
                        "groupId": "OG000",
                        "lowerLimit": "57",
                        "upperLimit": "85"
                      },
                      {
                        "value": "72",
                        "groupId": "OG001",
                        "lowerLimit": "58",
                        "upperLimit": "81"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Follow-up 3 Physical Well Being Chest-Arm 1:24 months (± 2 mo); Arm 2:30 months (± 2 mo)",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "68",
                        "groupId": "OG000",
                        "lowerLimit": "50",
                        "upperLimit": "88"
                      },
                      {
                        "value": "68",
                        "groupId": "OG001",
                        "lowerLimit": "60",
                        "upperLimit": "92"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Baseline Psychosocial Well Being",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "63",
                        "groupId": "OG000",
                        "lowerLimit": "50",
                        "upperLimit": "67"
                      },
                      {
                        "value": "67",
                        "groupId": "OG001",
                        "lowerLimit": "52",
                        "upperLimit": "84"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Follow-up 1 Psychosocial Well Being-Arm 1:12 months (± 2 mo); Arm 2:12-18 months (± 6 mo)",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "63",
                        "groupId": "OG000",
                        "lowerLimit": "53",
                        "upperLimit": "82"
                      },
                      {
                        "value": "67",
                        "groupId": "OG001",
                        "lowerLimit": "50",
                        "upperLimit": "86"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Follow-up 2 Psychosocial Well Being-Arm 1:12-18 months (± 6 mo); Arm 2:18 months (± 2 mo)",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "63",
                        "groupId": "OG000",
                        "lowerLimit": "52",
                        "upperLimit": "70"
                      },
                      {
                        "value": "63",
                        "groupId": "OG001",
                        "lowerLimit": "48",
                        "upperLimit": "77"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Follow-up 3 Psychosocial Well Being-Arm 1:24 months (± 2 mo); Arm 2:30 months (± 2 mo)",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "62",
                        "groupId": "OG000",
                        "lowerLimit": "50",
                        "upperLimit": "68"
                      },
                      {
                        "value": "70",
                        "groupId": "OG001",
                        "lowerLimit": "52",
                        "upperLimit": "100"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Baseline Satisfaction with Breasts",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "58",
                        "groupId": "OG000",
                        "lowerLimit": "52",
                        "upperLimit": "66"
                      },
                      {
                        "value": "52",
                        "groupId": "OG001",
                        "lowerLimit": "42",
                        "upperLimit": "62"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Follow-up 1 Satisfaction with Breasts-Arm 1:12 months (± 2 mo); Arm 2:12-18 months (± 6 mo)",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "59",
                        "groupId": "OG000",
                        "lowerLimit": "48",
                        "upperLimit": "79"
                      },
                      {
                        "value": "59",
                        "groupId": "OG001",
                        "lowerLimit": "48",
                        "upperLimit": "79"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Follow-up 2 Satisfaction with Breasts-Arm 1:12-18 months (± 6 mo); Arm 2:18 months (± 2 mo)",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "52",
                        "groupId": "OG000",
                        "lowerLimit": "44",
                        "upperLimit": "73"
                      },
                      {
                        "value": "48",
                        "groupId": "OG001",
                        "lowerLimit": "40",
                        "upperLimit": "74"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Follow-up 3 Satisfaction with Breasts-Arm 1:24 months (± 2 mo); Arm 2:30 months (± 2 mo)",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "50",
                        "groupId": "OG000",
                        "lowerLimit": "43",
                        "upperLimit": "60"
                      },
                      {
                        "value": "58",
                        "groupId": "OG001",
                        "lowerLimit": "39",
                        "upperLimit": "78"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Baseline Satisfaction with Outcome",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "67",
                        "groupId": "OG000",
                        "lowerLimit": "60",
                        "upperLimit": "69"
                      },
                      {
                        "value": "67",
                        "groupId": "OG001",
                        "lowerLimit": "47",
                        "upperLimit": "75"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Follow-up 1 Satisfaction with Outcome-Arm 1:12 months (± 2 mo); Arm 2:12-18 months (± 6 mo)",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "67",
                        "groupId": "OG000",
                        "lowerLimit": "50",
                        "upperLimit": "75"
                      },
                      {
                        "value": "67",
                        "groupId": "OG001",
                        "lowerLimit": "57",
                        "upperLimit": "75"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Follow-up 2 Satisfaction with Outcome-Arm 1:12-18 months (± 6 mo); Arm 2:18 months (± 2 mo)",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "61",
                        "groupId": "OG000",
                        "lowerLimit": "47",
                        "upperLimit": "75"
                      },
                      {
                        "value": "61",
                        "groupId": "OG001",
                        "lowerLimit": "47",
                        "upperLimit": "75"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Follow-up 3 Satisfaction with Outcome-Arm 1:24 months (± 2 mo); Arm 2:30 months (± 2 mo)",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "0",
                        "groupId": "OG000",
                        "lowerLimit": "0",
                        "upperLimit": "0"
                      },
                      {
                        "value": "55",
                        "groupId": "OG001",
                        "lowerLimit": "40",
                        "upperLimit": "70"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Baseline Sexual Well Being",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "51",
                        "groupId": "OG000",
                        "lowerLimit": "46",
                        "upperLimit": "56"
                      },
                      {
                        "value": "43",
                        "groupId": "OG001",
                        "lowerLimit": "34",
                        "upperLimit": "55"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Follow-up 1 Sexual Well Being-Arm 1:12 months (± 2 mo); Arm 2:12-18 months (± 6 mo)",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "45",
                        "groupId": "OG000",
                        "lowerLimit": "36",
                        "upperLimit": "52"
                      },
                      {
                        "value": "47",
                        "groupId": "OG001",
                        "lowerLimit": "38",
                        "upperLimit": "52"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Follow-up 2 Sexual Well Being-Arm 1:12-18 months (± 6 mo); Arm 2:18 months (± 2 mo)",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "45",
                        "groupId": "OG000",
                        "lowerLimit": "37",
                        "upperLimit": "52"
                      },
                      {
                        "value": "39",
                        "groupId": "OG001",
                        "lowerLimit": "32",
                        "upperLimit": "60"
                      }
                    ]
                  }
                ]
              },
              {
                "title": "Follow-up 3 Sexual Well Being-Arm 1:24 months (± 2 mo); Arm 2:30 months (± 2 mo)",
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "41",
                        "groupId": "OG000",
                        "lowerLimit": "27",
                        "upperLimit": "50"
                      },
                      {
                        "value": "48",
                        "groupId": "OG001",
                        "lowerLimit": "27",
                        "upperLimit": "66"
                      }
                    ]
                  }
                ]
              }
            ],
            "paramType": "MEAN",
            "timeFrame": "Baseline, Follow-up 1 (Arm 1:12 months (± 2 mo); Arm 2:12-18 months (± 6 mo)), Follow-up 2 (Arm 1:12-18 months (± 6 mo); Arm 2:18 months (± 2 mo)), and Follow-up 3 (Arm 1:24 months (± 2 mo); Arm 2:30 months (± 2 mo))",
            "description": "To evaluate cosmesis, the Breast-Q© will be utilized in these assessments and will be presented descriptively, giving summary statistics for changes in the Breast-Q© scores over time.\nWith a focus on the post-operative period, the module will evaluate changes over time in four of the six subthemes identified by Breast-Q: (1) Psychosocial well-being; (2) Physical well-being; (3) Satisfaction with breasts; and (4) Satisfaction with outcome.\nEach subtheme will be evaluated using one or more scales.\nEach scale is independently scored into a value that ranges from 0 to 100, with higher score indicating greater satisfaction or better health-related quality of life.",
            "unitOfMeasure": "scores on a scale",
            "dispersionType": "Full Range",
            "reportingStatus": "POSTED"
          }
        ]
      },
      "participantFlowModule": {
        "groups": [
          {
            "id": "FG000",
            "title": "IMRT to Temporary Expander",
            "description": "<p>Physical examination by MD, optional Breast MRI, Breast-Q© at baseline (after permanent implant exchange, physical exam and Breast-Q© may be done after the initiation of IMRT), 12 ± 2 months and 24 ± 2 months post- IMRT.\nTotal length of the follow-up time will be 24 ± 2 months post-IMRT.\nA subset of 10 left-sided patients will receive 13N-NH3 PET scans within the radiation simulation session.\nA CT for coronary calcium scoring and a low-dose CT for attenuation correction will also be obtained at this time.\nMyocardial blood flow will be measured during rest and at peak stress with 13N-NH3 as a perfusion tracer.\nA follow-up 13N-NH3 PET study with low-dose CT for attenuation correction will be obtained 12-18 months (± 6 months) post-IMRT.</p><p>Breast MRI</p><p>Breast-Q© questionnaire</p><p>Multi-Beam IMRT: The radiation dose (50-50.4\nGy&#x2F;25-28 fractions in approximately 5-6 weeks), treatment-planning and delivery aspects are according to departmental guidelines for breast IMRT.</p>"
          },
          {
            "id": "FG001",
            "title": "IMRT to Permanent Implant",
            "description": "<p>Physical examination by MD, optional Breast MRI, Breast-Q © at baseline (after permanent implant exchange and after IMRT), 18 ± 2 months and 30 ± 2 months post-IMRT, as these patients will undergo exchange of the temporary expander for the permanent implant approximately 4-8 months following the completion of radiation (at the discretion of the treating plastic surgeon).\nTotal length of the follow-up time will be 30 ± 2 months post-IMRT</p><p>Breast MRI</p><p>Breast-Q© questionnaire</p><p>Multi-Beam IMRT: The radiation dose (50-50.4\nGy&#x2F;25-28 fractions in approximately 5-6 weeks), treatment-planning and delivery aspects are according to departmental guidelines for breast IMRT.</p>"
          }
        ],
        "periods": [
          {
            "title": "Overall Study",
            "milestones": [
              {
                "type": "STARTED",
                "achievements": [
                  {
                    "groupId": "FG000",
                    "numSubjects": "42"
                  },
                  {
                    "groupId": "FG001",
                    "numSubjects": "58"
                  }
                ]
              },
              {
                "type": "COMPLETED",
                "achievements": [
                  {
                    "groupId": "FG000",
                    "numSubjects": "42"
                  },
                  {
                    "groupId": "FG001",
                    "numSubjects": "58"
                  }
                ]
              },
              {
                "type": "NOT COMPLETED",
                "achievements": [
                  {
                    "groupId": "FG000",
                    "numSubjects": "0"
                  },
                  {
                    "groupId": "FG001",
                    "numSubjects": "0"
                  }
                ]
              }
            ]
          }
        ]
      },
      "baselineCharacteristicsModule": {
        "denoms": [
          {
            "units": "Participants",
            "counts": [
              {
                "value": "42",
                "groupId": "BG000"
              },
              {
                "value": "58",
                "groupId": "BG001"
              },
              {
                "value": "100",
                "groupId": "BG002"
              }
            ]
          }
        ],
        "groups": [
          {
            "id": "BG000",
            "title": "IMRT to Temporary Expander",
            "description": "<p>Physical examination by MD, optional Breast MRI, Breast-Q© at baseline (after permanent implant exchange, physical exam and Breast-Q© may be done after the initiation of IMRT), 12 ± 2 months and 24 ± 2 months post- IMRT.\nTotal length of the follow-up time will be 24 ± 2 months post-IMRT.\nA subset of 10 left-sided patients will receive 13N-NH3 PET scans within the radiation simulation session.\nA CT for coronary calcium scoring and a low-dose CT for attenuation correction will also be obtained at this time.\nMyocardial blood flow will be measured during rest and at peak stress with 13N-NH3 as a perfusion tracer.\nA follow-up 13N-NH3 PET study with low-dose CT for attenuation correction will be obtained 12-18 months (± 6 months) post-IMRT.</p><p>Breast MRI</p><p>Breast-Q© questionnaire</p><p>Multi-Beam IMRT: The radiation dose (50-50.4\nGy&#x2F;25-28 fractions in approximately 5-6 weeks), treatment-planning and delivery aspects are according to departmental guidelines for breast IMRT.</p>"
          },
          {
            "id": "BG001",
            "title": "IMRT to Permanent Implant",
            "description": "<p>Physical examination by MD, optional Breast MRI, Breast-Q © at baseline (after permanent implant exchange and after IMRT), 18 ± 2 months and 30 ± 2 months post-IMRT, as these patients will undergo exchange of the temporary expander for the permanent implant approximately 4-8 months following the completion of radiation (at the discretion of the treating plastic surgeon).\nTotal length of the follow-up time will be 30 ± 2 months post-IMRT</p><p>Breast MRI</p><p>Breast-Q© questionnaire</p><p>Multi-Beam IMRT: The radiation dose (50-50.4\nGy&#x2F;25-28 fractions in approximately 5-6 weeks), treatment-planning and delivery aspects are according to departmental guidelines for breast IMRT.</p>"
          },
          {
            "id": "BG002",
            "title": "Total",
            "description": "Total of all reporting groups"
          }
        ],
        "measures": [
          {
            "title": "Age, Continuous",
            "classes": [
              {
                "categories": [
                  {
                    "measurements": [
                      {
                        "value": "56",
                        "groupId": "BG000",
                        "lowerLimit": "46",
                        "upperLimit": "60"
                      },
                      {
                        "value": "54",
                        "groupId": "BG001",
                        "lowerLimit": "46",
                        "upperLimit": "64"
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                      {
                        "value": "54",
                        "groupId": "BG002",
                        "lowerLimit": "46",
                        "upperLimit": "64"
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                    ]
                  }
                ]
              }
            ],
            "paramType": "MEDIAN",
            "unitOfMeasure": "years",
            "dispersionType": "FULL_RANGE"
          },
          {
            "title": "Sex: Female, Male",
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              {
                "categories": [
                  {
                    "title": "Female",
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                        "value": "100",
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                    ]
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                      {
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                      {
                        "value": "0",
                        "groupId": "BG002"
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                    ]
                  }
                ]
              }
            ],
            "paramType": "COUNT_OF_PARTICIPANTS",
            "unitOfMeasure": "Participants"
          },
          {
            "title": "Ethnicity (NIH&#x2F;OMB)",
            "classes": [
              {
                "categories": [
                  {
                    "title": "Hispanic or Latino",
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                      {
                        "value": "2",
                        "groupId": "BG000"
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                        "value": "7",
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                  },
                  {
                    "title": "Not Hispanic or Latino",
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                        "value": "40",
                        "groupId": "BG000"
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                      {
                        "value": "53",
                        "groupId": "BG001"
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                      {
                        "value": "93",
                        "groupId": "BG002"
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                    ]
                  },
                  {
                    "title": "Unknown or Not Reported",
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                      {
                        "value": "0",
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                      {
                        "value": "0",
                        "groupId": "BG001"
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                      {
                        "value": "0",
                        "groupId": "BG002"
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                    ]
                  }
                ]
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            ],
            "paramType": "COUNT_OF_PARTICIPANTS",
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          {
            "title": "Race (NIH&#x2F;OMB)",
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              {
                "categories": [
                  {
                    "title": "American Indian or Alaska Native",
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                      {
                        "value": "0",
                        "groupId": "BG000"
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                        "value": "0",
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                        "value": "0",
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                  {
                    "title": "Asian",
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                        "value": "2",
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                      {
                        "value": "8",
                        "groupId": "BG001"
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                        "value": "10",
                        "groupId": "BG002"
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                    ]
                  },
                  {
                    "title": "Native Hawaiian or Other Pacific Islander",
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                        "value": "0",
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                        "groupId": "BG001"
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                        "groupId": "BG000"
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                        "value": "39",
                        "groupId": "BG001"
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                      {
                        "value": "69",
                        "groupId": "BG002"
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                    ]
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                    "title": "More than one race",
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                        "value": "0",
                        "groupId": "BG000"
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                        "value": "0",
                        "groupId": "BG001"
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                        "value": "0",
                        "groupId": "BG002"
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                        "groupId": "BG001"
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                      {
                        "value": "12",
                        "groupId": "BG002"
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          {
            "title": "Region of Enrollment",
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                    "measurements": [
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                        "groupId": "BG000"
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                        "groupId": "BG001"
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                        "value": "100",
                        "groupId": "BG002"
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                  }
                ]
              }
            ],
            "paramType": "COUNT_OF_PARTICIPANTS",
            "unitOfMeasure": "Participants"
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        ],
        "populationDescription": "Includes participants who were able to complete study treatment."
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