IMAGE GUIDED SURGERY FOR TUMOR DETECTION IN SOLID TUMORS USING THE PHACTIVATED PROBE ONM-100
- Conditions
- Solid tumor typesBreast cancerEsophageal cancerColorectal cancerHead and Neck cancer
- Registration Number
- NL-OMON29368
- Lead Sponsor
- OncoNano Medicine Inc., Texas, USA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 33
Inclusion Criteria
1) Biopsy confirmed diagnosis of primary or recurrent respective tumor type and scheduled
to undergo surgical
Exclusion Criteria
1) Medical or psychiatric conditions that compromise the patient’s ability to give
informed consent.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - To evaluate safety and pharmacokinetics of a single dose of ONM-100 administered<br>intravenously in patients with solid tumors (HNSCC, Breast Cancer, Colorectal Cancer<br>and Esophageal cancer)<br /><br>- To assess the feasibility of using ONM-100 for intraoperative imaging of solid tumors<br>(HNSCC, Breast Cancer, Colorectal Cancer and Esophageal Cancer).
- Secondary Outcome Measures
Name Time Method - To determine a range of safe doses of ONM-100 for intra-operative imaging of solid<br>tumors and metastatic nodes with an adequate Tumor to Background Contrast Ratio<br>(CNR).<br /><br>o Breast tumors will be used in phase 1a to determine optimal dose for phase 1b<br>(see section 3, study design)<br /><br>- To evaluate suitability of commonly used camera systems for intra-operative imaging<br>with ONM-100 (Novadaq and/or Surgvision imaging systems)