Using [18F]NOTA-ABY030 PET/CT to clarify indeterminate head and neck squamous cell carcinoma lesions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase I, single-institution, open-label study gives adults with head and neck squamous cell carcinoma a 50 mg cetuximab loading dose followed by a bolus of [18F]NOTA-ABY030 and performs PET/CT scans at set time points to map tracer biodistribution and lesion uptake. The investigational agent is an anti-EGFR affibody radiolabeled for rapid clearance and improved tumor-to-background contrast. Primary endpoints focus on safety and tolerability, while secondary endpoints include radiation dosimetry and comparison of sensitivity and specificity to MRI, CT, and [18F]FDG-PET/CT. Imaging results will be compared to conventional modalities to see if the agent reduces uncertain findings and unnecessary biopsies.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥ 18 years.
2. Subjects diagnosed with any T stage, any subsite within the head and neck. Subjects with recurrent disease or a new primary will be allowed.
3. 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
4. Have acceptable lab values, including the following clinical results (if values are considered clinically significant per investigator, participants must be asymptomatic):

   1. Hemoglobin ≥ 9gm/dL
   2. White blood cell count \> 3000/mm3
   3. Platelet count ≥ 100,000/mm3
   4. Serum creatinine ≤ 1.5 times upper reference range
   5. Potassium
   6. Magnesium
   7. Phosphorus

Exclusion Criteria:

1. Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment.
2. Prior severe infusion reactions or hypersensitivity to other monoclonal antibody therapies.
3. Pregnant (based on Screening serum or urine pregnancy test administered before infusions), or breastfeeding.
4. Participants with known hypersensitivity to NOTA-ABY-030, cetuximab, murine, or any of the drug components used in this trial.
5. Subjects with history or evidence of interstitial pneumonitis or pulmonary fibrosis.
6. Severe renal disease or anuria.
7. Participants presenting with a baseline QTcF interval \> than 480 milliseconds.
8. Those with an allergy to red meat, a history of tick bites, and alpha-gal syndrome will be given extra consideration.

Where it's running

• Vanderbilt University Medical Center
  Nashville, Tennessee, United States Recruiting

Study contacts

• Principal investigator: Eben Rosenthal, MD — Vanderbilt University Medical Center
• Study coordinator: Nicole Jones
• Email: nicole.l.jones@vumc.org
• Phone: 615-936-2807

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.