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

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    Recruiting
  • participants needed
    45
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Updated on 19 February 2024

Summary

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.

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Condition surgery,tumor
Age 18years - 99years
Clinical Study Identifier03735680
Last Modified on19 February 2024

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