NCT03735680

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

Version 3 to 4 · OncoNano Medicine, Inc.

Patch inspector

Version 3 to 4

6 operations 3 path groups ctgov_internal_history

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_change

Value signals

[
  {
    "path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
    "signal": "timeline_shift",
    "category": "timeline_shift",
    "new_type": "ESTIMATED",
    "old_type": "ESTIMATED",
    "severity": "medium",
    "direction": "later",
    "new_value": "2020-11-30",
    "old_value": "2020-09-30",
    "delta_days": 61,
    "date_struct": "primaryCompletionDateStruct",
    "new_precision": "day",
    "old_precision": "day"
  },
  {
    "path": "/protocolSection/statusModule/completionDateStruct/date",
    "signal": "timeline_shift",
    "category": "timeline_shift",
    "new_type": "ESTIMATED",
    "old_type": "ESTIMATED",
    "severity": "medium",
    "direction": "later",
    "new_value": "2020-12-31",
    "old_value": "2020-10-31",
    "delta_days": 61,
    "date_struct": "completionDateStruct",
    "new_precision": "day",
    "old_precision": "day"
  }
]

Provenance

Source: ctgov_internal_history
Fetched: 2026-06-18 18:57:37+00
Raw hash: 88a1fe486b812146cbce67a2abd8d70cb625539e218b6797b7b566c5b4186283
Payload: Source URL

Eligibility Criteria and population definition changes. Triage: High 1 ops

replace /protocolSection/eligibilityModule/eligibilityCriteria

Triage: High

Eligibility Change Operation 6

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, 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>

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 &gt;5) or significant liver disease including active hepatitis or cirrhosis</li></ul>

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

2020-09-30

After

2020-11-30

replace /protocolSection/statusModule/completionDateStruct/date

Triage: Medium

Timeline Shift Operation 3

Matched rules

completion_timeline_change Completion date changes are operational timeline signals.

Before

2020-10-31

After

2020-12-31

Other registry fields Changes outside the current high-signal rule families. Triage: Uncategorized 3 ops

replace /protocolSection/statusModule/statusVerifiedDate

Triage: Uncategorized

Uncategorized Operation 1

Before

2020-08

After

2020-09

replace /protocolSection/statusModule/lastUpdateSubmitDate

Triage: Uncategorized

Uncategorized Operation 4

Before

2020-08-05

After

2020-09-01

replace /protocolSection/statusModule/lastUpdatePostDateStruct/date

Triage: Uncategorized

Uncategorized Operation 5

Before

2020-08-07

After

2020-09-03

Raw JSON Patch

[
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/statusVerifiedDate",
    "value": "2020-09"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
    "value": "2020-11-30"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/completionDateStruct/date",
    "value": "2020-12-31"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2020-09-01"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2020-09-03"
  },
  {
    "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 &gt;5) or significant liver disease including active hepatitis or cirrhosis</li></ul>"
  }
]