Panitumumab-IRDye800 and 89Zr-Panitumumab in Identifying Metastatic Lymph Nodes in Patients With Squamous Cell Head and Neck Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Carcinoma of the Head and Neck
- Squamous Cell Carcinoma of the Head and Neck
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Diagnostic
Participation Requirements
- Age
- Between 19 years and 125 years
- Gender
- Both males and females
Description
Participants receive standard of care 18F-FDG-PET/CT and/or 18F-FDG-PET/MRI to assess their cancer for surgical excision. Participants than receive panitumumab-IRDye800 dye and 89Zr-panitumumab, both by intravenous (IV) infusion, on Day 0. Participants will undergo 89Zr-panitumumab PET/CT imaging on...
Participants receive standard of care 18F-FDG-PET/CT and/or 18F-FDG-PET/MRI to assess their cancer for surgical excision. Participants than receive panitumumab-IRDye800 dye and 89Zr-panitumumab, both by intravenous (IV) infusion, on Day 0. Participants will undergo 89Zr-panitumumab PET/CT imaging on Day 1 to 2, and then undergo surgical resection of the tumor at 2 to 5 days after infusion. Participants with cancer-positive lymph nodes vs cancer-negative lymph nodes will be analyzed as separate cohorts. Research imaging will be performed intraoperatively using optical imaging devices and a high-energy gamma probe. Subsequently, the excised tissue will evaluated ex vivo (back table) using radioactive (89Zr-panitumumab) and fluorescence (panitumumab-IRDye800) imaging techniques. After surgery, patients are followed up at 15 and 30 days. PRIMARY OBJECTIVES: I. Determine the sensitivity and specificity of zirconium Zr 89 panitumumab (89Zr panitumumab) for the detection of tumor-involved regional lymph nodes. SECONDARY OBJECTIVES: I. Determine the number (proportion) of lymph nodes determined to be tumor positive by histological and/or pathological evaluation that were NOT predicted tumor-positive by 89Zr panitumumab labeling. EXPLORATORY OBJECTIVES: I. Determine the sensitivity and specificity of panitumumab IRDye800 for the detection of tumor-involved regional lymph nodes. II. Determine the number (proportion) of lymph nodes determined to be tumor positive by histological and/or pathological evaluation that were NOT predicted tumor-positive by panitumumab-IRdye800 labeling. optical imaging devices listed in Appendix B intraoperative high-energy gamma probe.
Tracking Information
- NCT #
- NCT03733210
- Collaborators
- National Institutes of Health (NIH)
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Eben Rosenthal, MD Stanford Cancer Institute Palo Alto
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