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NCT03735680

A Study to Evaluate ONM-100, an Intraoperative Fluorescence Imaging Agent for the Detection of Cancer

Version 1 to 2 · OncoNano Medicine, Inc.

Patch inspector

Version 1 to 2

19 operations 6 path groups ctgov_internal_history
ClinicalTrials.gov
Severity is deterministic uncalibrated triage metadata, not validated review priority. Operation-level severity is inferred from deterministic path rules. Rule matches shown per operation are approximate previews (they skip the pipeline's suppression passes); the authoritative classification is the stored event record.
Plain-language summary

Manual review pending.

Rules fired
eligibility_criteria_changeprimary_outcome_any_changesecondary_outcome_any_change
Value signals
[
  {
    "path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
    "signal": "timeline_significant_shift",
    "category": "timeline_significant_shift",
    "new_type": "ESTIMATED",
    "old_type": "ESTIMATED",
    "severity": "medium",
    "direction": "later",
    "new_value": "2020-09-30",
    "old_value": "2019-12-31",
    "delta_days": 274,
    "date_struct": "primaryCompletionDateStruct",
    "new_precision": "day",
    "old_precision": "day"
  },
  {
    "path": "/protocolSection/statusModule/completionDateStruct/date",
    "signal": "timeline_significant_shift",
    "category": "timeline_significant_shift",
    "new_type": "ESTIMATED",
    "old_type": "ESTIMATED",
    "severity": "medium",
    "direction": "later",
    "new_value": "2020-10-31",
    "old_value": "2020-01-31",
    "delta_days": 274,
    "date_struct": "completionDateStruct",
    "new_precision": "day",
    "old_precision": "day"
  }
]
Provenance
Source
ctgov_internal_history
Fetched
2026-06-18 18:57:36+00
Raw hash
9e2e95170893914d1386192b54319370851d31f4c763310bb374560f3bd9cec4
Payload
Source URL
Primary outcomes Outcome measures that define the trial's primary evidence target. Triage: Critical 2 ops
replace /protocolSection/outcomesModule/primaryOutcomes/1/measure
Triage: Critical
Primary Outcome Change Operation 9
Matched rules
  • primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority.
Before
Incidence rate of all treatment-emergent adverse events (TEAEs) from time of ONM-100 administration through Day 14
After
Incidence rate of all treatment-emergent adverse events (TEAEs) from time of ONM-100 administration through Day 28
replace /protocolSection/outcomesModule/primaryOutcomes/1/timeFrame
Triage: Critical
Primary Outcome Change Operation 10
Matched rules
  • primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority.
Before
14 days
After
28 days
Eligibility Criteria and population definition changes. Triage: High 1 ops
replace /protocolSection/eligibilityModule/eligibilityCriteria
Triage: High
Eligibility Change Operation 17
Matched rules
  • eligibility_criteria_change Eligibility criteria changes can alter the studied population.
Before
<p>Inclusion Criteria:</p><ul><li>Biopsy-confirmed diagnosis of primary or recurrent respective tumor type and scheduled to undergo surgical resection</li><li>Part 1: Biopsy-confirmed diagnosis of head and neck squamous cell carcinoma (HNSCC) or breast cancer</li><li>Part 2: Biopsy-confirmed diagnosis of HNSCC, breast cancer, colorectal cancer, prostate cancer, bladder cancer, and ovarian cancer</li></ul><p>Exclusion Criteria:</p><ul><li>Histologically diagnosed by an open biopsy procedure</li><li>Tumors at sites of which the surgeon would assess that in vivo intraoperative imaging would not be feasible</li><li>Life expectancy &lt;12 weeks</li><li>Significant liver disease including active hepatitis, cirrhosis, or alanine aminotransferase or bilirubin above upper limit of normal</li></ul>
After
<p>Inclusion Criteria:</p><ul><li>Biopsy-confirmed diagnosis of primary or recurrent respective tumor type and scheduled to undergo surgical resection</li><li>Part 1: Biopsy-confirmed diagnosis of head and neck squamous cell carcinoma (HNSCC) or breast cancer</li><li>Part 2: Biopsy-confirmed diagnosis of HNSCC, breast cancer, colorectal cancer, prostate cancer, ovarian cancer, urothelial carcinoma and non-small cell lung cancer.</li></ul><p>Exclusion Criteria:</p><ul><li>Histologically diagnosed by an excisional biopsy procedure</li><li>Tumors at sites of which the surgeon would assess that in vivo intraoperative imaging would not be feasible</li><li>Life expectancy &lt;12 weeks</li><li>Hepatic impairment (Child-Pugh score ≥5) or significant liver disease including active hepatitis or cirrhosis</li></ul>
Secondary outcomes Additional endpoints and outcome descriptions. Triage: High 6 ops
replace /protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame
Triage: High
Secondary Outcome Change Operation 11
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
9 days
After
6 days
replace /protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame
Triage: High
Secondary Outcome Change Operation 12
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
9 days
After
6 days
replace /protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame
Triage: High
Secondary Outcome Change Operation 13
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
9 days
After
6 days
replace /protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame
Triage: High
Secondary Outcome Change Operation 14
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
9 days
After
6 days
replace /protocolSection/outcomesModule/secondaryOutcomes/4/timeFrame
Triage: High
Secondary Outcome Change Operation 15
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
9 days
After
6 days
replace /protocolSection/outcomesModule/secondaryOutcomes/5/timeFrame
Triage: High
Secondary Outcome Change Operation 16
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
9 days
After
6 days
Timeline Start, primary completion, and completion date movement. Triage: Medium 2 ops
replace /protocolSection/statusModule/primaryCompletionDateStruct/date
Triage: Medium
Timeline Shift Operation 2
Matched rules
  • primary_completion_timeline_change Primary completion date changes are operational timeline signals.
Before
2019-12-31
After
2020-09-30
replace /protocolSection/statusModule/completionDateStruct/date
Triage: Medium
Timeline Shift Operation 3
Matched rules
  • completion_timeline_change Completion date changes are operational timeline signals.
Before
2020-01-31
After
2020-10-31
Contacts and locations Site, contact, and location updates that are usually operational. Triage: Uncategorized 2 ops
add /protocolSection/contactsLocationsModule/locations/0
Triage: Uncategorized
Uncategorized Operation 18
After
{
  "zip": "19104",
  "city": "Philadelphia",
  "state": "Pennsylvania",
  "status": "RECRUITING",
  "country": "United States",
  "contacts": [
    {
      "name": "Ari Brooks, MD",
      "role": "CONTACT"
    }
  ],
  "facility": "The University of Pennsylvania",
  "geoPoint": {
    "lat": 39.95238,
    "lon": -75.16362
  }
}
add /protocolSection/contactsLocationsModule/locations/2
Triage: Uncategorized
Uncategorized Operation 19
After
{
  "zip": "77030",
  "city": "Houston",
  "state": "Texas",
  "status": "NOT_YET_RECRUITING",
  "country": "United States",
  "contacts": [
    {
      "name": "Kelly Hunt, MD",
      "role": "CONTACT"
    }
  ],
  "facility": "The University of Texas - M.D. Anderson Cancer Center",
  "geoPoint": {
    "lat": 29.76328,
    "lon": -95.36327
  }
}
Other registry fields Changes outside the current high-signal rule families. Triage: Uncategorized 6 ops
replace /protocolSection/statusModule/statusVerifiedDate
Triage: Uncategorized
Uncategorized Operation 1
Before
2019-08
After
2020-02
replace /protocolSection/statusModule/lastUpdateSubmitDate
Triage: Uncategorized
Uncategorized Operation 4
Before
2019-08-27
After
2020-02-12
replace /protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Uncategorized
Uncategorized Operation 5
Before
2019-08-29
After
2020-02-13
remove /protocolSection/conditionsModule/conditions/3
Triage: Uncategorized
Uncategorized Operation 6
Before
Bladder Cancer
add /protocolSection/conditionsModule/conditions/5
Triage: Uncategorized
Uncategorized Operation 7
After
Urothelial Carcinoma
add /protocolSection/conditionsModule/conditions/6
Triage: Uncategorized
Uncategorized Operation 8
After
Non-small Cell Lung Cancer
Raw JSON Patch 
[
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/statusVerifiedDate",
    "value": "2020-02"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
    "value": "2020-09-30"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/completionDateStruct/date",
    "value": "2020-10-31"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2020-02-12"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2020-02-13"
  },
  {
    "op": "remove",
    "path": "/protocolSection/conditionsModule/conditions/3"
  },
  {
    "op": "add",
    "path": "/protocolSection/conditionsModule/conditions/5",
    "value": "Urothelial Carcinoma"
  },
  {
    "op": "add",
    "path": "/protocolSection/conditionsModule/conditions/6",
    "value": "Non-small Cell Lung Cancer"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/primaryOutcomes/1/measure",
    "value": "Incidence rate of all treatment-emergent adverse events (TEAEs) from time of ONM-100 administration through Day 28"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/primaryOutcomes/1/timeFrame",
    "value": "28 days"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame",
    "value": "6 days"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame",
    "value": "6 days"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame",
    "value": "6 days"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame",
    "value": "6 days"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/4/timeFrame",
    "value": "6 days"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/5/timeFrame",
    "value": "6 days"
  },
  {
    "op": "replace",
    "path": "/protocolSection/eligibilityModule/eligibilityCriteria",
    "value": "<p>Inclusion Criteria:</p><ul><li>Biopsy-confirmed diagnosis of primary or recurrent respective tumor type and scheduled to undergo surgical resection</li><li>Part 1: Biopsy-confirmed diagnosis of head and neck squamous cell carcinoma (HNSCC) or breast cancer</li><li>Part 2: Biopsy-confirmed diagnosis of HNSCC, breast cancer, colorectal cancer, prostate cancer, ovarian cancer, urothelial carcinoma and non-small cell lung cancer.</li></ul><p>Exclusion Criteria:</p><ul><li>Histologically diagnosed by an excisional biopsy procedure</li><li>Tumors at sites of which the surgeon would assess that in vivo intraoperative imaging would not be feasible</li><li>Life expectancy &lt;12 weeks</li><li>Hepatic impairment (Child-Pugh score ≥5) or significant liver disease including active hepatitis or cirrhosis</li></ul>"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/0",
    "value": {
      "zip": "19104",
      "city": "Philadelphia",
      "state": "Pennsylvania",
      "status": "RECRUITING",
      "country": "United States",
      "contacts": [
        {
          "name": "Ari Brooks, MD",
          "role": "CONTACT"
        }
      ],
      "facility": "The University of Pennsylvania",
      "geoPoint": {
        "lat": 39.95238,
        "lon": -75.16362
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/2",
    "value": {
      "zip": "77030",
      "city": "Houston",
      "state": "Texas",
      "status": "NOT_YET_RECRUITING",
      "country": "United States",
      "contacts": [
        {
          "name": "Kelly Hunt, MD",
          "role": "CONTACT"
        }
      ],
      "facility": "The University of Texas - M.D. Anderson Cancer Center",
      "geoPoint": {
        "lat": 29.76328,
        "lon": -95.36327
      }
    }
  }
]