Study to Evaluate Imaging Feasibility, Safety and Diagnostic Performance Post Dosing of an Intraoperative Fluorescent Imaging Agent for Detection of Metastatic Lymph Nodes Primary Tumors and Tumor Margins in Patients with Solid Tumors

Study to Evaluate Imaging Feasibility,  Safety and Diagnostic Performance Post Dosing of an Intraoperative Fluorescent Imaging Agent for Detection of Metastatic Lymph Nodes  Primary Tumors and Tumor Margins in Patients with Solid Tumors
Recruiting
18 years - 99 years
All
Phase 2
45 participants needed
1 Location

Brief description of study

The purpose of this research study is to learn about the safety and effectiveness of using ONM 100 to obtain images of primary tumors and metastatic lymph nodes in patients with solid tumors undergoing routine surgery. Adults at least 18 years of age with a Biopsy-confirmed diagnosis of primary or recurrent respective tumor type and scheduled to undergo surgical resection will be recruited to participate in this study. There are two parts to this study. Patients will be recruited if they have the following diagnoses: Part 1: Biopsy-confirmed diagnosis of Stage 0 to 4 HNSCC or primary breast cancer. Part 2: Biopsy-confirmed diagnosis of Stage 2 to 4 or higher HNSCC, breast cancer, colorectal cancer, prostate cancer, bladder cancer, ovarian cancer The study intervention is an IV dose of ONM-100, which is an intraoperative fluorescence imaging agent. The main purpose of this study is to investigate whether ONM-100 can be used to image primary tumors and metastatic lymph nodes at time points earlier than 24 ±8 hours in patients undergoing routine surgery of their solid cancers and whether the diagnostic performance to detect metastatic lymph nodes can be improved by optimizing the dose and the imaging time.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: surgery,tumor
  • Age: 18 years - 99 years
  • Gender: All


Updated on 19 Feb 2024. Study ID: 833066

Find a site

Message sent successfully.
We have submitted the information you provided to the research team at the location you chose. For your records, we have sent a copy of the message to your email address.
If you would like to be informed of other studies that may be of interest to you, you may sign up for Patient Notification Service.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Preferred way of contact
Race
Ethnicity
Other language

Message For Non Enrolling By Invitation Trial

Select a study center that’s convenient for you, and get in touch with the study team.