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Study Evaluating the Safety and Feasibility of Panitumumab-IRDye800 and [18F]NOTA-ABY-030 for Targeted Dual-Modality Imaging (TDMI) in Head and Neck Squamous Cell Carcinoma
Sponsor: Vanderbilt-Ingram Cancer Center
Summary
The goal of this clinical trial is to learn whether using two imaging agents-Panitumumab-IRDye800 (Pan800) and\[18F\]NOTA-ABY-030-is safe and feasible for helping surgeons identify tumors and cancer-containing lymph nodes during surgery in adults with head and neck squamous cell carcinoma (HNSCC) who are scheduled for tumor removal and neck dissection. The main questions it aims to answer are: * Is the combination of Pan800 and \[18F\]NOTA-ABY-030 safe and well tolerated in patients undergoing surgery for HNSCC? * How accurately can Pan800 and \[18F\]NOTA-ABY-030 detect tumor tissue and cancer-positive lymph nodes when compared with final pathology results? This is a single-arm, open-label study, so there is no comparison group. Study Related Steps: * Receive an intravenous infusion of Pan800 1-2 days before surgery. * Receive an intravenous injection of\[18F\]NOTA-ABY-030 on the day of surgery.
Official title: Phase I Open-Label Study Evaluating the Safety and Feasibility of Panitumumab-IRDye800 and [18F]NOTA-ABY-030 for Targeted Dual-Modality Imaging (TDMI) in Head and Neck Squamous Cell Carcinoma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2026-10
Completion Date
2031-07
Last Updated
2026-10-19
Healthy Volunteers
No
Conditions
Interventions
Panitumumab-IRDye800
IV Infusion of 50 mg dose of Panitumumab-IRDye800 (Pan800) 1-2 days before surgery.
[18F]NOTA-ABY-030
Single intravenous bolus injection of approximately 5 mCi (±10%) in the operating room prior to tumor removal and neck dissection.
Locations (1)
Vanderbilt University Medical Center
Nashville, Tennessee, United States