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NCT03735680 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate ONM-100, an Intraoperative Fluorescence Imaging Agent for the Detection of Cancer
A Phase 2 study of Breast Cancer and Prostate Cancer, sponsored by OncoNano Medicine.
- Completed
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
- 3
- Study locations
NCT03735680: Completed Phase 2 study of Breast Cancer and Prostate Cancer, sponsored by OncoNano Medicine.
NCT03735680 is a Phase 2 study of Breast Cancer and Prostate Cancer that has completed, run by OncoNano Medicine. The registered enrollment target is 30 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03735680, a Phase 2 study of Breast Cancer and Prostate Cancer, has completed, sponsored by OncoNano Medicine.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
- 3
- Study locations
Study 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.
Primary Outcome
Part 1: Evaluate the dose(s) at which ONM-100 fluorescence imaging is feasible at 3±2 hours post dose. Part 2: Verify the safety and diagnostic performance of ONM-100 compared to standard pathology at the dose(s) and imaging schedule(s) post dose selected from Part 1 for the detection of primary tumors and the metastatic lymph nodes in a variety of solid cancers (which could have included HNSCC, breast cancer, colorectal cancer, urothelial cancer, prostate cancer, ovarian cancer, and/or non-sma
Conditions Studied
Interventions
- DRUG ONM-100
Study Locations (3)
Texas
- The University of Texas Southwestern Medical Center - Dallas
- The University of Texas - M.D. Anderson Cancer Center - Houston
Pennsylvania
- The University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2019-08-09 |
| Est. Completion | 2021-11-18 |
| Phase | Phase 2 |
What the finished NCT03735680 record still lists
NCT03735680 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower).
The record links to 7 conditions, with Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which ONM-100 is the first listed.
NCT03735680 reports a single indexed study location in Texas, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT03735680 about?
NCT03735680 is a clinical study titled "A Study to Evaluate ONM-100, an Intraoperative Fluorescence Imaging Agent for the Detection of Cancer". 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.
What is the current status of trial NCT03735680?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2019-08-09. Estimated completion is 2021-11-18.
What conditions does trial NCT03735680 study?
This clinical trial studies the following conditions: Breast Cancer, Prostate Cancer, Non-Small Cell Lung Cancer, Colorectal Cancer, Ovarian Cancer.
What interventions are being tested in trial NCT03735680?
The interventions under investigation include: ONM-100 (DRUG).
Who is sponsoring clinical trial NCT03735680?
This trial is sponsored by OncoNano Medicine, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03735680 being conducted?
This trial has 3 study locations across Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03735680's enrollment target sits among peer trials
30 955th of 1224 higher than 227 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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