Study Evaluating [18F]NOTA-ABY030 for Safety and Tolerability of Indeterminate Primary and/or Metastatic Disease in Head and Neck Squamous Cell Carcinoma
This Phase I, single-institution, open-label study will evaluate the safety, tolerability, and diagnostic performance of \[18F\]NOTA-ABY030 PET/CT in patients with head and neck squamous cell carcinoma (HNSCC) who present with indeterminate lesions on standard imaging. The investigational agent is a radiolabeled anti-EGFR affibody designed for rapid clearance and improved tumor-to-background contrast. All participants will receive a 50 mg cetuximab loading dose followed by a bolus of \[18F\]NOTA-ABY030, with PET/CT imaging performed at defined intervals to assess biodistribution and lesion uptake. The primary objective is to determine safety and tolerability; secondary objectives include radiation dosimetry and comparison of sensitivity and specificity to conventional imaging modalities (MRI, CT, and \[18F\]FDG-PET/CT). This approach aims to improve diagnostic accuracy, reduce unnecessary biopsies, and streamline treatment decisions for patients with HNSCC.
• Age ≥ 18 years.
• Subjects diagnosed with any T stage, any subsite within the head and neck. Subjects with recurrent disease or a new primary will be allowed.
• Must have evidence of indeterminate metastatic and/or primary SCC based on clinical imaging or Primary SCC with suspicious Lymph Nodes standard image modalities prior to surgical removal
• Have acceptable lab values, including the following clinical results (if values are considered clinically significant per investigator, participants must be asymptomatic):
‣ Hemoglobin ≥ 9gm/dL
⁃ White blood cell count \> 3000/mm3
⁃ Platelet count ≥ 100,000/mm3
⁃ Serum creatinine ≤ 1.5 times upper reference range
⁃ Potassium
⁃ Magnesium
⁃ Phosphorus