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.

NCT Number	NCT07217028
Lead Sponsor	Vanderbilt-Ingram Cancer Center
Conditions	SCC - Squamous Cell Carcinoma, Radiotracer, Head and Neck Squamous Cell Carcinoma, Metastatic Head and Neck Squamous Cell Carcinoma
Enrollment	25 participants
Start Date	2026-04-24
Primary Completion	2029-04 (estimated)
Study Completion	2030-09 (estimated)
Updated on ClinicalTrials.gov	2026-05-11