Trials / Completed
CompletedNCT03735680
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- OncoNano Medicine, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Breast Cancer
- Head and Neck Squamous Cell Carcinoma
- Colorectal Cancer
- Prostate Cancer
- Ovarian Cancer
- Urothelial Carcinoma
- Non-small Cell Lung Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ONM-100 | A polymer micelle covalently conjugated to indocyanine green. |
Timeline
- Start date
- 2019-08-09
- Primary completion
- 2021-10-14
- Completion
- 2021-11-18
- First posted
- 2018-11-08
- Last updated
- 2023-07-07
- Results posted
- 2023-07-07
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03735680. Inclusion in this directory is not an endorsement.