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SCC - Squamous Cell CarcinomaDiagnostics and screeningDrugProcedurePhase 1

What this study is

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.

What's being tested

  • Cetuximab (EGFR inhibitor)

    Intervention · DRUG

    Given IV

  • 18F-NOTA-ABY-030

    Intervention · DRUG

    Given Bolus Injection

  • Positron Emission Tomography (PET)

    Intervention · PROCEDURE

    Undergo PET/CT

Study details

Sponsor
Vanderbilt-Ingram Cancer Center
Conditions
SCC - Squamous Cell Carcinoma · Radiotracer · Head and Neck Squamous Cell Carcinoma · Metastatic Head and Neck Squamous Cell Carcinoma
Enrolling
25 people
Starts
2026-04-24
Est. completion
2030-09
Design
Open-label, non-randomized, sequential groups, Phase 1
Record
View on ClinicalTrials.gov ↗