Breast Cancer Clinical Trial
A Study to Evaluate ONM-100, an Intraoperative Fluorescence Imaging Agent for the Detection of Cancer
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.
Eligibility Criteria
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
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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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