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NCT03735680

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

A Phase 2a, Single-dose, Open-label Study to Evaluate Diagnostic Performance, Safety & Timing of Postdose Imaging of ONM-100, an Intraoperative Fluorescence Imaging Agent for the Detection of Cancer, in Patients With Solid Tumors Undergoing Routine Surgery

ClinicalTrials.gov
Sponsor
OncoNano Medicine, Inc.
Status
Completed
Versions
13
Adjacent patches
12
Severity is deterministic, reproducible, uncalibrated triage metadata, not validated review priority or proven wrongdoing. New Evidence Record packages are generated for deterministic event-class membership, not by triage rank alone.

Material event timeline

12 shown
Triage: Medium
2019-08-27
Timeline Significant Shift
v0 to v1 Pre Recruitment Inspect patch
/protocolSection/contactsLocationsModule/locations
/protocolSection/statusModule/completionDateStruct/date
/protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Critical
2020-02-12
Primary Outcome Change
v1 to v2 Early Recruitment Inspect patch
/protocolSection/conditionsModule/conditions/3
/protocolSection/conditionsModule/conditions/5
/protocolSection/conditionsModule/conditions/6
Triage: High
2020-08-05
Enrollment Change
v2 to v3 Early Recruitment Inspect patch
/protocolSection/contactsLocationsModule/centralContacts/0/email
/protocolSection/contactsLocationsModule/centralContacts/0/name
/protocolSection/contactsLocationsModule/centralContacts/0/phone
Triage: High
2020-09-01
Eligibility Change
v3 to v4 Early Recruitment Inspect patch
/protocolSection/eligibilityModule/eligibilityCriteria
/protocolSection/statusModule/completionDateStruct/date
/protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: High
2021-01-12
Eligibility Change
v4 to v5 Early Recruitment Inspect patch
/protocolSection/eligibilityModule/eligibilityCriteria
/protocolSection/statusModule/completionDateStruct/date
/protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Medium
2021-06-24
Timeline Shift
v5 to v6 Early Recruitment Inspect patch
/protocolSection/contactsLocationsModule/locations/0/contacts/0/name
/protocolSection/contactsLocationsModule/locations/2/contacts/0/name
/protocolSection/contactsLocationsModule/locations/2/status
Triage: High
2021-10-14
Enrollment Change
v6 to v7 Early Recruitment Inspect patch
/protocolSection/contactsLocationsModule/centralContacts
/protocolSection/contactsLocationsModule/locations/0/contacts
/protocolSection/contactsLocationsModule/locations/0/status
Triage: Low
2022-02-09
Timeline Actualized Earlier
v7 to v8 Late Recruitment Inspect patch
/protocolSection/statusModule/completionDateStruct/date
/protocolSection/statusModule/completionDateStruct/type
/protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: High
2023-01-16
Arm Intervention Change
v8 to v9 Post Recruitment Inspect patch Evidence Record
/annotationSection
/documentSection
/hasResults
Triage: High
2023-04-19
Serious Adverse Event Modification
v9 to v10 Post Recruitment Inspect patch Evidence Record
/annotationSection/annotationModule/unpostedAnnotation/unpostedEvents/0/date
/protocolSection/outcomesModule/primaryOutcomes/0/reviewUnit
/protocolSection/outcomesModule/secondaryOutcomes/0/description
Triage: High
2023-05-23
Adverse Event Group Change
v10 to v11 Post Recruitment Inspect patch
/annotationSection/annotationModule/unpostedAnnotation/unpostedEvents/0/date
/protocolSection/statusModule/lastUpdatePostDateStruct/date
/protocolSection/statusModule/lastUpdateSubmitDate
Triage: High
2023-07-06
Serious Adverse Event Addition
v11 to v12 Post Recruitment Inspect patch
/annotationSection
/protocolSection/statusModule/lastUpdatePostDateStruct/date
/protocolSection/statusModule/lastUpdateSubmitDate