Overview

Study Evaluating [18F]NOTA-ABY030 for Safety and Tolerability of Indeterminate Primary and/or Metastatic Disease in Head and Neck Squamous Cell Carcinoma

Status:
NOT_YET_RECRUITING

Trial end date:
2031-04-01

Target enrollment:

Participant gender:

Summary

This Phase I clinical trial evaluates the safety, tolerability, and diagnostic performance of a novel PET imaging agent, \[18F\]NOTA-ABY030, 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 to improve tumor specificity and reduce background signal, potentially enhancing diagnostic accuracy. Participants receive a loading dose of cetuximab followed by \[18F\]NOTA-ABY030, with PET/CT imaging performed at defined intervals to assess biodistribution and lesion uptake. The study aims to determine the agent's safety profile, calculate radiation dosimetry, and compare its sensitivity and specificity to conventional imaging modalities such as MRI, CT, and \[18F\]FDG-PET/CT. This approach may reduce unnecessary biopsies and improve staging accuracy, ultimately streamlining treatment decisions for patients with HNSCC.

Phase:

PHASE1

Details

Lead Sponsor:

Vanderbilt-Ingram Cancer Center

Treatments:

Cetuximab
Magnetic Resonance Spectroscopy