At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 30 enrolled
Drug / intervention
ONM-100drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating ONM-100 for Breast Cancer and 6 related conditions. Completed, enrolled 30 participants across 3 sites.
Detailed Summary
This study is to evaluate diagnostic performance, safety and timing of post-dose imaging of ONM-100, an intraoperative fluorescence imaging agent for the detection of cancer in patients with solid tumors undergoing routine surgery.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer, Head and Neck Squamous Cell Carcinoma, Colorectal Cancer, Prostate Cancer, Ovarian Cancer, Urothelial Carcinoma, Non-small Cell Lung Cancer
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
First PostedNov 2018
Enrollment StartAug 2019
Primary CompletionOct 2021
Study CompletionNov 2021
TodayJul 2026
First PostedNov 8, 2018
Enrollment StartAug 9, 2019
Primary CompletionOct 14, 2021
Study CompletionNov 18, 2021
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 7.6 years ago
Interventions
ONM-100drug
A polymer micelle covalently conjugated to indocyanine green.