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CompletedPhase 2NCT03735680
Official study title

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

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.

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Key things to know

Main goalDiagnostic

This describes the study’s primary purpose.

What is being studiedONM-100

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jul 7, 2023 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?3 U.S. locations

Locations may change over time.

Who runs it?OncoNano Medicine, Inc.

Study sponsor

01
Study overview

What this study is about

Purpose
Diagnostic
Study type
Interventional
Phase
Phase 2
Sponsor
OncoNano Medicine, Inc.
Interventions being studied
Drug: ONM-100
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Treatment approach
Surgery→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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
Reasons someone may not be able to joinExclusion 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.

04
Study sites

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.

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