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.
Age ≥ 18 years.
Subjects diagnosed with any T stage, any subsite within the head and neck. Subjects with recurrent disease or a new primary will be allowed.
Must have evidence of indeterminate metastatic and/or primary SCC based on clinical imaging or Primary SCC with suspicious Lymph Nodes standard image modalities prior to surgical removal
Hemoglobin ≥ 9gm/dL
Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment.
Prior severe infusion reactions or hypersensitivity to other monoclonal antibody therapies.
Pregnant (based on Screening serum or urine pregnancy test administered before infusions), or breastfeeding.
Participants with known hypersensitivity to NOTA-ABY-030, cetuximab, murine, or any of the drug components used in this trial.
Sequential
Cetuximab (EGFR inhibitor)
DrugGiven IV
18F-NOTA-ABY-030
DrugGiven Bolus Injection
Positron Emission Tomography (PET)
Procedure/SurgeryUndergo PET/CT
Assess number, grade and severity of adverse events to determine safety and tolerability of [18F]NOTA-ABY-030 in human subjects.
As determined by the number of adverse events (AEs) that are possibly or probably related to the study drug within 24 hours after infusion. Dose limiting toxicities will be defined as an AE grade \>2 that is clinically significant and attributable to the study drug.
Determination of the radiation dosimetry for [18F]NOTA-ABY-030 in human subjects.
The dosimetry for \[18F\]NOTA-ABY-030 will be determined to be the absorbed dose, organ specific uptake, critical organs, and effective dose for this first-in-human radiopharmaceutical.
Compare sensitivity and specificity of standard of care imaging modalities (MRI, CT, and/or [18F]FDG PET/CT) to [18F]NOTA-ABY-030-PET/CT for detection of indeterminate metastatic and/or primary lesion(s) in HNSCC
The specificity and sensitivity of \[18F\]NOTA-ABY-030 will be compared to the specificity and sensitivity of standard of care imaging obtained (MRI, CT, and/or \[18F\]FDG PET/CT) for identification of metastatic or primary lesion.
Determine the sensitivity and specificity of [18F]NOTA-ABY-030 for the detection of indeterminate metastatic and/or primary lesion(s) in HNSCC.
The total number of HNSCC accurately detected by \[18F\]NOTA-ABY-030 compared to the number of positive disease during the 36 ± 6-month follow-up period (gold standard).
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Vanderbilt-Ingram Cancer Center
Lead sponsor
Vanderbilt University Medical Center
Sponsor institution
