Breast Cancer Clinical Trial
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.
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
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
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There are 3 Locations for this study
Philadelphia Pennsylvania, 19104, United States
Dallas Texas, 75390, United States
Houston Texas, 77030, United States
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