Actively Recruiting
Study Evaluating [18F]NOTA-ABY030 for Safety and Tolerability of Indeterminate Primary and/or Metastatic Disease in Head and Neck Squamous Cell Carcinoma
Led by Vanderbilt-Ingram Cancer Center · Updated on 2026-05-11
25
Participants Needed
1
Research Sites
227 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study Evaluating [18F]NOTA-ABY030 for Safety and Tolerability of Indeterminate Primary and/or Metastatic Disease in Head and Neck Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosed with any T stage of head and neck squamous cell carcinoma, including recurrent or new primary disease
- Evidence of indeterminate metastatic or primary squamous cell carcinoma based on clinical imaging or suspicious lymph nodes before surgery
- Acceptable laboratory values including hemoglobin ≥ 9 gm/dL, white blood cell count > 3000/mm3, platelet count ≥ 100,000/mm3, serum creatinine ≤ 1.5 times upper reference range, and normal potassium, magnesium, and phosphorus levels
You will not qualify if you...
- Myocardial infarction, stroke, uncontrolled congestive heart failure, significant liver disease, or unstable angina within 6 months before enrollment
- Prior severe infusion reactions or hypersensitivity to monoclonal antibody therapies
- Pregnant or breastfeeding
- Known hypersensitivity to NOTA-ABY-030, cetuximab, murine proteins, or any trial drug components
- History or evidence of interstitial pneumonitis or pulmonary fibrosis
- Severe kidney disease or absence of urine production
- Baseline QTcF interval greater than 480 milliseconds
- Allergy to red meat, history of tick bites, or alpha-gal syndrome requiring extra consideration
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
Research Team
N
Nicole Jones
CONTACT
M
Makenna Brown
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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