Using [18F]NOTA-ABY030 PET/CT to clarify indeterminate head and neck squamous cell carcinoma lesions
Study Evaluating [18F]NOTA-ABY030 for Safety and Tolerability of Indeterminate Primary and/or Metastatic Disease in Head and Neck Squamous Cell Carcinoma
This trial will test whether the new PET imaging agent [18F]NOTA-ABY030 is safe and can better detect unclear primary or metastatic lesions in adults with head and neck squamous cell carcinoma.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Vanderbilt-Ingram Cancer Center Academic / other |
| Drugs / interventions | cetuximab, radiation |
| Locations | 1 site (Nashville, Tennessee) |
| Trial ID | NCT07217028 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18) with confirmed head and neck squamous cell carcinoma who have indeterminate primary or metastatic lesions on standard imaging and meet lab and safety criteria are ideal candidates.
Not a fit: Patients without indeterminate lesions, those with recent serious cardiac or liver conditions, or those with prior severe infusion reactions or contraindications to cetuximab or PET imaging are unlikely to benefit.
Why it matters
Potential benefit: If successful, this imaging approach could improve detection of unclear tumors, reduce unnecessary biopsies, and help doctors choose treatments faster.
How similar studies have performed: Early preclinical and limited early-phase clinical work with anti-EGFR affibodies and other targeted PET tracers has shown promising tumor targeting, but clinical data for [18F]NOTA-ABY030 are still very limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Nashville, Tennessee
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.