Physical examination by MD, optional Breast MRI, Breast-Q\u00a9 at baseline (after permanent implant exchange, physical exam and Breast-Q\u00a9 may be done after the initiation of IMRT), 12 \u00b1 2 months and 24 \u00b1 2 months post- IMRT.\nTotal length of the follow-up time will be 24 \u00b1 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 (\u00b1 6 months) post-IMRT.
Breast MRI
Breast-Q\u00a9 questionnaire
Multi-Beam IMRT: The radiation dose (50-50.4\nGy/25-28 fractions in approximately 5-6 weeks), treatment-planning and delivery aspects are according to departmental guidelines for breast IMRT.
","id":"EG000","otherNumAffected":32,"otherNumAtRisk":42,"seriousNumAffected":3,"seriousNumAtRisk":42,"title":"IMRT to Temporary Expander"},{"deathsNumAffected":8,"deathsNumAtRisk":58,"description":"Physical examination by MD, optional Breast MRI, Breast-Q \u00a9 at baseline (after permanent implant exchange and after IMRT), 18 \u00b1 2 months and 30 \u00b1 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 \u00b1 2 months post-IMRT
Breast MRI
Breast-Q\u00a9 questionnaire
Multi-Beam IMRT: The radiation dose (50-50.4\nGy/25-28 fractions in approximately 5-6 weeks), treatment-planning and delivery aspects are according to departmental guidelines for breast IMRT.
","id":"EG001","otherNumAffected":58,"otherNumAtRisk":58,"seriousNumAffected":15,"seriousNumAtRisk":58,"title":"IMRT to Permanent Implant"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42},{"groupId":"EG001","numAffected":1,"numAtRisk":58}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42},{"groupId":"EG001","numAffected":6,"numAtRisk":58}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42},{"groupId":"EG001","numAffected":1,"numAtRisk":58}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42},{"groupId":"EG001","numAffected":4,"numAtRisk":58}],"term":"Hyperglycemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42},{"groupId":"EG001","numAffected":1,"numAtRisk":58}],"term":"Hypoalbuminemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42},{"groupId":"EG001","numAffected":3,"numAtRisk":58}],"term":"Hypocalcemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42},{"groupId":"EG001","numAffected":1,"numAtRisk":58}],"term":"Hypokalemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42},{"groupId":"EG001","numAffected":1,"numAtRisk":58}],"term":"Hypomagnesemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42},{"groupId":"EG001","numAffected":1,"numAtRisk":58}],"term":"Hyponatremia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42},{"groupId":"EG001","numAffected":1,"numAtRisk":58}],"term":"Hypophosphatemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":42},{"groupId":"EG001","numAffected":33,"numAtRisk":58}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":42},{"groupId":"EG001","numAffected":7,"numAtRisk":58}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42},{"groupId":"EG001","numAffected":1,"numAtRisk":58}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":42},{"groupId":"EG001","numAffected":16,"numAtRisk":58}],"term":"White blood cell decreased"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":42},{"groupId":"EG001","numAffected":7,"numAtRisk":58}],"term":"Breast infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42},{"groupId":"EG001","numAffected":1,"numAtRisk":58}],"term":"Breast pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42},{"groupId":"EG001","numAffected":1,"numAtRisk":58}],"term":"Chest pain - cardiac"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42},{"groupId":"EG001","numAffected":1,"numAtRisk":58}],"term":"Chest wall pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42},{"groupId":"EG001","numAffected":2,"numAtRisk":58}],"term":"Dyspnea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":42},{"groupId":"EG001","numAffected":0,"numAtRisk":58}],"term":"Gastrointestinal disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42},{"groupId":"EG001","numAffected":1,"numAtRisk":58}],"term":"Hypoxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42},{"groupId":"EG001","numAffected":1,"numAtRisk":58}],"term":"Infections and infestations - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42},{"groupId":"EG001","numAffected":1,"numAtRisk":58}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42},{"groupId":"EG001","numAffected":1,"numAtRisk":58}],"term":"Non-cardiac chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42},{"groupId":"EG001","numAffected":1,"numAtRisk":58}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42},{"groupId":"EG001","numAffected":1,"numAtRisk":58}],"term":"Pneumonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":42},{"groupId":"EG001","numAffected":0,"numAtRisk":58}],"term":"Skin infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":42},{"groupId":"EG001","numAffected":1,"numAtRisk":58}],"term":"Wound dehiscence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42},{"groupId":"EG001","numAffected":2,"numAtRisk":58}],"term":"Wound infection"}],"timeFrame":"2 years"},"baselineCharacteristicsModule":{"denoms":[{"counts":[{"groupId":"BG000","value":"42"},{"groupId":"BG001","value":"58"},{"groupId":"BG002","value":"100"}],"units":"Participants"}],"groups":[{"description":"Physical examination by MD, optional Breast MRI, Breast-Q\u00a9 at baseline (after permanent implant exchange, physical exam and Breast-Q\u00a9 may be done after the initiation of IMRT), 12 \u00b1 2 months and 24 \u00b1 2 months post- IMRT.\nTotal length of the follow-up time will be 24 \u00b1 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 (\u00b1 6 months) post-IMRT.
Breast MRI
Breast-Q\u00a9 questionnaire
Multi-Beam IMRT: The radiation dose (50-50.4\nGy/25-28 fractions in approximately 5-6 weeks), treatment-planning and delivery aspects are according to departmental guidelines for breast IMRT.
","id":"BG000","title":"IMRT to Temporary Expander"},{"description":"Physical examination by MD, optional Breast MRI, Breast-Q \u00a9 at baseline (after permanent implant exchange and after IMRT), 18 \u00b1 2 months and 30 \u00b1 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 \u00b1 2 months post-IMRT
Breast MRI
Breast-Q\u00a9 questionnaire
Multi-Beam IMRT: The radiation dose (50-50.4\nGy/25-28 fractions in approximately 5-6 weeks), treatment-planning and delivery aspects are according to departmental guidelines for breast IMRT.
","id":"BG001","title":"IMRT to Permanent Implant"},{"description":"Total of all reporting groups","id":"BG002","title":"Total"}],"measures":[{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","lowerLimit":"46","upperLimit":"60","value":"56"},{"groupId":"BG001","lowerLimit":"46","upperLimit":"64","value":"54"},{"groupId":"BG002","lowerLimit":"46","upperLimit":"64","value":"54"}]}]}],"dispersionType":"FULL_RANGE","paramType":"MEDIAN","title":"Age, Continuous","unitOfMeasure":"years"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"42"},{"groupId":"BG001","value":"58"},{"groupId":"BG002","value":"100"}],"title":"Female"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"Male"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Sex: Female, Male","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"7"}],"title":"Hispanic or Latino"},{"measurements":[{"groupId":"BG000","value":"40"},{"groupId":"BG001","value":"53"},{"groupId":"BG002","value":"93"}],"title":"Not Hispanic or Latino"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"Unknown or Not Reported"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Ethnicity (NIH/OMB)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"American Indian or Alaska Native"},{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"8"},{"groupId":"BG002","value":"10"}],"title":"Asian"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"Native Hawaiian or Other Pacific Islander"},{"measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"9"}],"title":"Black or African American"},{"measurements":[{"groupId":"BG000","value":"30"},{"groupId":"BG001","value":"39"},{"groupId":"BG002","value":"69"}],"title":"White"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"More than one race"},{"measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"7"},{"groupId":"BG002","value":"12"}],"title":"Unknown or Not Reported"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Race (NIH/OMB)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"42"},{"groupId":"BG001","value":"58"},{"groupId":"BG002","value":"100"}]}],"title":"United States"}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Region of Enrollment","unitOfMeasure":"Participants"}],"populationDescription":"Includes participants who were able to complete study treatment."},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":true},"pointOfContact":{"email":"gelblumd@MSKCC.ORG","organization":"Memorial Sloan Kettering Cancer Center","phone":"914-367-7273","title":"Dr. Daphna Gelblum, MD"}},"outcomeMeasuresModule":{"outcomeMeasures":[{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"17"}]}],"title":"Implant Failure"},{"categories":[{"measurements":[{"groupId":"OG000","value":"34"},{"groupId":"OG001","value":"41"}]}],"title":"No Implant Failure"}],"denoms":[{"counts":[{"groupId":"OG000","value":"42"},{"groupId":"OG001","value":"58"}],"units":"Participants"}],"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).","groups":[{"description":"Physical examination by MD, optional Breast MRI, Breast-Q\u00a9 at baseline (after permanent implant exchange, physical exam and Breast-Q\u00a9 may be done after the initiation of IMRT), 12 \u00b1 2 months and 24 \u00b1 2 months post- IMRT.\nTotal length of the follow-up time will be 24 \u00b1 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 (\u00b1 6 months) post-IMRT.
Breast MRI
Breast-Q\u00a9 questionnaire
Multi-Beam IMRT: The radiation dose (50-50.4\nGy/25-28 fractions in approximately 5-6 weeks), treatment-planning and delivery aspects are according to departmental guidelines for breast IMRT.
","id":"OG000","title":"IMRT to Temporary Expander"},{"description":"Physical examination by MD, optional Breast MRI, Breast-Q \u00a9 at baseline (after permanent implant exchange and after IMRT), 18 \u00b1 2 months and 30 \u00b1 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 \u00b1 2 months post-IMRT
Breast MRI
Breast-Q\u00a9 questionnaire
Multi-Beam IMRT: The radiation dose (50-50.4\nGy/25-28 fractions in approximately 5-6 weeks), treatment-planning and delivery aspects are according to departmental guidelines for breast IMRT.
","id":"OG001","title":"IMRT to Permanent Implant"}],"paramType":"NUMBER","reportingStatus":"POSTED","timeFrame":"24 months post-IMRT for Group 1, and 30 months post-IMRT for Group 2","title":"Incidence of Implant Failure","type":"PRIMARY","unitOfMeasure":"Number of Participants with Implant Fail"},{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"26"},{"groupId":"OG001","value":"36"}],"title":"Grade IA-II Capsular Contracture"},{"measurements":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"11"}],"title":"Grade III-IV Capsular Contracture"},{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"11"}],"title":"No Capsular Contracture"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"42"},{"groupId":"OG001","value":"58"}],"units":"Participants"}],"description":"Will be examined using number of participants who developed Baker's grade <2 and \u22652 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.","groups":[{"description":"Physical examination by MD, optional Breast MRI, Breast-Q\u00a9 at baseline (after permanent implant exchange, physical exam and Breast-Q\u00a9 may be done after the initiation of IMRT), 12 \u00b1 2 months and 24 \u00b1 2 months post- IMRT.\nTotal length of the follow-up time will be 24 \u00b1 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 (\u00b1 6 months) post-IMRT.
Breast MRI
Breast-Q\u00a9 questionnaire
Multi-Beam IMRT: The radiation dose (50-50.4\nGy/25-28 fractions in approximately 5-6 weeks), treatment-planning and delivery aspects are according to departmental guidelines for breast IMRT.
","id":"OG000","title":"IMRT to Temporary Expander"},{"description":"Physical examination by MD, optional Breast MRI, Breast-Q \u00a9 at baseline (after permanent implant exchange and after IMRT), 18 \u00b1 2 months and 30 \u00b1 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 \u00b1 2 months post-IMRT
Breast MRI
Breast-Q\u00a9 questionnaire
Multi-Beam IMRT: The radiation dose (50-50.4\nGy/25-28 fractions in approximately 5-6 weeks), treatment-planning and delivery aspects are according to departmental guidelines for breast IMRT.
","id":"OG001","title":"IMRT to Permanent Implant"}],"paramType":"COUNT_OF_PARTICIPANTS","reportingStatus":"POSTED","timeFrame":"24 months post-IMRT for Group 1, and 30 months post-IMRT for Group 2","title":"Incidence of Moderate to Severe Capsular Contracture","type":"SECONDARY","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"2"}],"title":"Participants with minor surgical corrections"},{"measurements":[{"groupId":"OG000","value":"42"},{"groupId":"OG001","value":"56"}],"title":"Participants without minor surgical corrections"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"42"},{"groupId":"OG001","value":"58"}],"units":"Participants"}],"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.","groups":[{"description":"Physical examination by MD, optional Breast MRI, Breast-Q\u00a9 at baseline (after permanent implant exchange, physical exam and Breast-Q\u00a9 may be done after the initiation of IMRT), 12 \u00b1 2 months and 24 \u00b1 2 months post- IMRT.\nTotal length of the follow-up time will be 24 \u00b1 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 (\u00b1 6 months) post-IMRT.
Breast MRI
Breast-Q\u00a9 questionnaire
Multi-Beam IMRT: The radiation dose (50-50.4\nGy/25-28 fractions in approximately 5-6 weeks), treatment-planning and delivery aspects are according to departmental guidelines for breast IMRT.
","id":"OG000","title":"IMRT to Temporary Expander"},{"description":"Physical examination by MD, optional Breast MRI, Breast-Q \u00a9 at baseline (after permanent implant exchange and after IMRT), 18 \u00b1 2 months and 30 \u00b1 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 \u00b1 2 months post-IMRT
Breast MRI
Breast-Q\u00a9 questionnaire
Multi-Beam IMRT: The radiation dose (50-50.4\nGy/25-28 fractions in approximately 5-6 weeks), treatment-planning and delivery aspects are according to departmental guidelines for breast IMRT.
","id":"OG001","title":"IMRT to Permanent Implant"}],"paramType":"COUNT_OF_PARTICIPANTS","reportingStatus":"POSTED","timeFrame":"2 years","title":"Rates of Minor Revisional Surgeries","type":"SECONDARY","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"76","upperLimit":"92","value":"84"},{"groupId":"OG001","lowerLimit":"59","upperLimit":"92","value":"64"}]}],"title":"Baseline Physical Well Being Abdomen"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"53","upperLimit":"74","value":"70"},{"groupId":"OG001","lowerLimit":"47","upperLimit":"70","value":"59"}]}],"title":"Follow-up 1 Physical Well Being Abdomen-Arm 1:12 months (\u00b1 2 mo); Arm 2:12-18 months (\u00b1 6 mo)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"62","upperLimit":"79","value":"76"},{"groupId":"OG001","lowerLimit":"46","upperLimit":"82","value":"69"}]}],"title":"Follow-up 2 Physical Well Being Abdomen-Arm 1:12-18 months (\u00b1 6 mo); Arm 2:18 months (\u00b1 2 mo)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"45","upperLimit":"72","value":"69"},{"groupId":"OG001","lowerLimit":"0","upperLimit":"75","value":"50"}]}],"title":"Follow-up 3 Physical Well Being Abdomen-Arm 1:24 months (\u00b1 2 mo); Arm 2:30 months (\u00b1 2 mo)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"58","upperLimit":"83","value":"68"},{"groupId":"OG001","lowerLimit":"55","upperLimit":"67","value":"60"}]}],"title":"Baseline Physical Well Being Chest"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"50","upperLimit":"74","value":"61"},{"groupId":"OG001","lowerLimit":"53","upperLimit":"84","value":"63"}]}],"title":"Follow-up 1 Physical Well Being Chest-Arm 1:12 months (\u00b1 2 mo); Arm 2:12-18 months (\u00b1 6 mo)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"57","upperLimit":"85","value":"66"},{"groupId":"OG001","lowerLimit":"58","upperLimit":"81","value":"72"}]}],"title":"Follow-up 2 Physical Well Being Chest-Arm 1:12-18 months (\u00b1 6 mo); Arm 2:18 months (\u00b1 2 mo)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"50","upperLimit":"88","value":"68"},{"groupId":"OG001","lowerLimit":"60","upperLimit":"92","value":"68"}]}],"title":"Follow-up 3 Physical Well Being Chest-Arm 1:24 months (\u00b1 2 mo); Arm 2:30 months (\u00b1 2 mo)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"50","upperLimit":"67","value":"63"},{"groupId":"OG001","lowerLimit":"52","upperLimit":"84","value":"67"}]}],"title":"Baseline Psychosocial Well Being"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"53","upperLimit":"82","value":"63"},{"groupId":"OG001","lowerLimit":"50","upperLimit":"86","value":"67"}]}],"title":"Follow-up 1 Psychosocial Well Being-Arm 1:12 months (\u00b1 2 mo); Arm 2:12-18 months (\u00b1 6 mo)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"52","upperLimit":"70","value":"63"},{"groupId":"OG001","lowerLimit":"48","upperLimit":"77","value":"63"}]}],"title":"Follow-up 2 Psychosocial Well Being-Arm 1:12-18 months (\u00b1 6 mo); Arm 2:18 months (\u00b1 2 mo)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"50","upperLimit":"68","value":"62"},{"groupId":"OG001","lowerLimit":"52","upperLimit":"100","value":"70"}]}],"title":"Follow-up 3 Psychosocial Well Being-Arm 1:24 months (\u00b1 2 mo); Arm 2:30 months (\u00b1 2 mo)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"52","upperLimit":"66","value":"58"},{"groupId":"OG001","lowerLimit":"42","upperLimit":"62","value":"52"}]}],"title":"Baseline Satisfaction with Breasts"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"48","upperLimit":"79","value":"59"},{"groupId":"OG001","lowerLimit":"48","upperLimit":"79","value":"59"}]}],"title":"Follow-up 1 Satisfaction with Breasts-Arm 1:12 months (\u00b1 2 mo); Arm 2:12-18 months (\u00b1 6 mo)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"44","upperLimit":"73","value":"52"},{"groupId":"OG001","lowerLimit":"40","upperLimit":"74","value":"48"}]}],"title":"Follow-up 2 Satisfaction with Breasts-Arm 1:12-18 months (\u00b1 6 mo); Arm 2:18 months (\u00b1 2 mo)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"43","upperLimit":"60","value":"50"},{"groupId":"OG001","lowerLimit":"39","upperLimit":"78","value":"58"}]}],"title":"Follow-up 3 Satisfaction with Breasts-Arm 1:24 months (\u00b1 2 mo); Arm 2:30 months (\u00b1 2 mo)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"60","upperLimit":"69","value":"67"},{"groupId":"OG001","lowerLimit":"47","upperLimit":"75","value":"67"}]}],"title":"Baseline Satisfaction with Outcome"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"50","upperLimit":"75","value":"67"},{"groupId":"OG001","lowerLimit":"57","upperLimit":"75","value":"67"}]}],"title":"Follow-up 1 Satisfaction with Outcome-Arm 1:12 months (\u00b1 2 mo); Arm 2:12-18 months (\u00b1 6 mo)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"47","upperLimit":"75","value":"61"},{"groupId":"OG001","lowerLimit":"47","upperLimit":"75","value":"61"}]}],"title":"Follow-up 2 Satisfaction with Outcome-Arm 1:12-18 months (\u00b1 6 mo); Arm 2:18 months (\u00b1 2 mo)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0","upperLimit":"0","value":"0"},{"groupId":"OG001","lowerLimit":"40","upperLimit":"70","value":"55"}]}],"title":"Follow-up 3 Satisfaction with Outcome-Arm 1:24 months (\u00b1 2 mo); Arm 2:30 months (\u00b1 2 mo)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"46","upperLimit":"56","value":"51"},{"groupId":"OG001","lowerLimit":"34","upperLimit":"55","value":"43"}]}],"title":"Baseline Sexual Well Being"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"36","upperLimit":"52","value":"45"},{"groupId":"OG001","lowerLimit":"38","upperLimit":"52","value":"47"}]}],"title":"Follow-up 1 Sexual Well Being-Arm 1:12 months (\u00b1 2 mo); Arm 2:12-18 months (\u00b1 6 mo)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"37","upperLimit":"52","value":"45"},{"groupId":"OG001","lowerLimit":"32","upperLimit":"60","value":"39"}]}],"title":"Follow-up 2 Sexual Well Being-Arm 1:12-18 months (\u00b1 6 mo); Arm 2:18 months (\u00b1 2 mo)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"27","upperLimit":"50","value":"41"},{"groupId":"OG001","lowerLimit":"27","upperLimit":"66","value":"48"}]}],"title":"Follow-up 3 Sexual Well Being-Arm 1:24 months (\u00b1 2 mo); Arm 2:30 months (\u00b1 2 mo)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"42"},{"groupId":"OG001","value":"58"}],"units":"Participants"}],"description":"To evaluate cosmesis, the Breast-Q\u00a9 will be utilized in these assessments and will be presented descriptively, giving summary statistics for changes in the Breast-Q\u00a9 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.","dispersionType":"Full Range","groups":[{"description":"Physical examination by MD, optional Breast MRI, Breast-Q\u00a9 at baseline (after permanent implant exchange, physical exam and Breast-Q\u00a9 may be done after the initiation of IMRT), 12 \u00b1 2 months and 24 \u00b1 2 months post- IMRT.\nTotal length of the follow-up time will be 24 \u00b1 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 (\u00b1 6 months) post-IMRT.
Breast MRI
Breast-Q\u00a9 questionnaire
Multi-Beam IMRT: The radiation dose (50-50.4\nGy/25-28 fractions in approximately 5-6 weeks), treatment-planning and delivery aspects are according to departmental guidelines for breast IMRT.
","id":"OG000","title":"Arm 1: IMRT to Temporary Expander"},{"description":"Physical examination by MD, optional Breast MRI, Breast-Q \u00a9 at baseline (after permanent implant exchange and after IMRT), 18 \u00b1 2 months and 30 \u00b1 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 \u00b1 2 months post-IMRT
Breast MRI
Breast-Q\u00a9 questionnaire
Multi-Beam IMRT: The radiation dose (50-50.4\nGy/25-28 fractions in approximately 5-6 weeks), treatment-planning and delivery aspects are according to departmental guidelines for breast IMRT.
","id":"OG001","title":"Arm 2: IMRT to Permanent Implant"}],"paramType":"MEAN","reportingStatus":"POSTED","timeFrame":"Baseline, Follow-up 1 (Arm 1:12 months (\u00b1 2 mo); Arm 2:12-18 months (\u00b1 6 mo)), Follow-up 2 (Arm 1:12-18 months (\u00b1 6 mo); Arm 2:18 months (\u00b1 2 mo)), and Follow-up 3 (Arm 1:24 months (\u00b1 2 mo); Arm 2:30 months (\u00b1 2 mo))","title":"Evaluate Cosmesis","type":"SECONDARY","unitOfMeasure":"scores on a scale"}]},"participantFlowModule":{"groups":[{"description":"Physical examination by MD, optional Breast MRI, Breast-Q\u00a9 at baseline (after permanent implant exchange, physical exam and Breast-Q\u00a9 may be done after the initiation of IMRT), 12 \u00b1 2 months and 24 \u00b1 2 months post- IMRT.\nTotal length of the follow-up time will be 24 \u00b1 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 (\u00b1 6 months) post-IMRT.
Breast MRI
Breast-Q\u00a9 questionnaire
Multi-Beam IMRT: The radiation dose (50-50.4\nGy/25-28 fractions in approximately 5-6 weeks), treatment-planning and delivery aspects are according to departmental guidelines for breast IMRT.
","id":"FG000","title":"IMRT to Temporary Expander"},{"description":"Physical examination by MD, optional Breast MRI, Breast-Q \u00a9 at baseline (after permanent implant exchange and after IMRT), 18 \u00b1 2 months and 30 \u00b1 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 \u00b1 2 months post-IMRT
Breast MRI
Breast-Q\u00a9 questionnaire
Multi-Beam IMRT: The radiation dose (50-50.4\nGy/25-28 fractions in approximately 5-6 weeks), treatment-planning and delivery aspects are according to departmental guidelines for breast IMRT.
","id":"FG001","title":"IMRT to Permanent Implant"}],"periods":[{"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"42"},{"groupId":"FG001","numSubjects":"58"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"42"},{"groupId":"FG001","numSubjects":"58"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}]}}},{"op":"add","path":"/documentSection","value":{"largeDocumentModule":{"largeDocs":[{"date":"2019-03-11","filename":"Prot_SAP_000.pdf","hasIcf":false,"hasProtocol":true,"hasSap":true,"label":"Study Protocol and Statistical Analysis Plan","size":1143140,"typeAbbrev":"Prot_SAP","uploadDate":"2025-08-26T15:19"}]}}}],"provenance":{"from_snapshot_hash":"267e8fccbd9a1463b77a27a80985598183554b6ef2b3dcf653a797198a28705f","materiality_event_hash":"07ba0865d9aa9628b150ba562231447844189290c4d7a10dd4341a79e082c556","patch_hash":"e59bd38a334e9cfe407b4168210ecab2dad30612c3549963e6c36b8fa419d22e","patch_raw_hash":"58e8c4e51cd50ee262902e0f6a5dbac600ad9b9aaaa0fa1d7e79275e01fdcc30","patch_source":"ctgov_internal_history","patch_source_url":"https://clinicaltrials.gov/api/int/studies/NCT02086578/history/23?patchToVersion=24","to_snapshot_hash":null},"review_question":"What source document explains this registry amendment, and does it change interpretation of the trial record?","schema":"trialdiff.evidence_record","trial":{"clinicaltrials_gov_url":"https://clinicaltrials.gov/study/NCT02086578","nct_id":"NCT02086578"},"versions":{"from_version":23,"submitted_date":"2025-12-30","to_version":24}}