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

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Recruitment opened Start date changed from estimate of Apr 2026 to Apr 24, 2026 · Site details revisedv6 Show 2 more changesShow less
    • Start date changed from estimate of Apr 2026 to Apr 24, 2026
    • Site details revised
  2. Enrollment reduced: 60 → 25 participantsv5
  3. Start date: Jan 2026 to Apr 2026 Primary completion date: Nov 2029 to Apr 2029 · Completion date: Apr 2031 to Sep 2030v4 Show 2 more changesShow less
    • Primary completion date: Nov 2029 to Apr 2029
    • Completion date: Apr 2031 to Sep 2030
  4. Start date: Nov 2025 to Jan 2026v3
  5. Primary endpoint revisedv2 See this version in full on ClinicalTrials.gov ↗
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
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
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov