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.
Age ≥ 18 years.
Subjects diagnosed with any T stage or N stage squamous cell carcinoma and any subsite within the head and neck that are scheduled to undergo surgical resection and neck dissection. Subjects with recurrent disease or a new primary will be allowed.
Hemoglobin ≥ 9 gm/dL
White blood cell count > 3000/mm3
Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment.
Evidence of QTcF prolongation on ECG within 30 days of pan800 administration (greater than 480 ms).
History of infusion reactions to monoclonal antibody therapies.
History of allergies to iodine.
Sequential
Panitumumab-IRDye800
DrugIV Infusion of 50 mg dose of Panitumumab-IRDye800 (Pan800) 1-2 days before surgery.
[18F]NOTA-ABY-030
DrugSingle intravenous bolus injection of approximately 5 mCi (±10%) in the operating room prior to tumor removal and neck dissection.
Record and evaluate the number events considered clinically significant Grade ≥2 AEs that are considered possibly, probably, or definitely related to [¹⁸F]NOTA-ABY-030, pan800, or both agents.
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Vanderbilt-Ingram Cancer Center
Lead sponsor
Vanderbilt University Medical Center
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options:
