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.
Checked against the public recordLast updated Jul 7, 2023 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Diagnostic
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- OncoNano Medicine, Inc.
- Interventions being studied
- Drug: ONM-100
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion Criteria: * Biopsy-confirmed diagnosis of primary or recurrent respective tumor type and scheduled to undergo surgical resection * Part 1: Biopsy-confirmed diagnosis of head and neck squamous cell carcinoma (HNSCC) or breast cancer * Part 2: Biopsy-confirmed diagnosis of HNSCC, breast cancer, colorectal cancer, prostate cancer, ovarian cancer, urothelial carcinoma and non-small cell lung cancer. * Part 3: Stage 2 to 4 HNSCC Including T0 or Tx unknown Primary cancers Exclusion Criteria: * Histologically diagnosed by an excisional biopsy procedure * Tumors at sites of which the surgeon would assess that in vivo intraoperative imaging would not be feasible * Life expectancy \<12 weeks * Hepatic impairment (Child-Pugh score \>5) or significant liver disease including active hepatitis or cirrhosis
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- The University of PennsylvaniaPhiladelphia, Pennsylvania
- The University of Texas Southwestern Medical CenterDallas, Texas
- The University of Texas - M.D. Anderson Cancer CenterHouston, Texas
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 7, 2023. Always confirm current availability with the study team.