SCC - Squamous Cell Carcinoma, Radiotracer, Head and Neck Squamous Cell Carcinoma, Metastatic Head and Neck Squamous Cell Carcinoma
Conditions
Keywords
unknown primary, cancer, hnscc, scc
Brief summary
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.
Interventions
Given IV
DRUG18F-NOTA-ABY-030
Given Bolus Injection
PROCEDUREPositron Emission Tomography (PET)
Undergo PET/CT
Sponsors
Vanderbilt-Ingram Cancer Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess number, grade and severity of adverse events to determine safety and tolerability of [18F]NOTA-ABY-030 in human subjects. | From infusion to 7 days post-infusion | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Determination of the radiation dosimetry for [18F]NOTA-ABY-030 in human subjects. | From infusion to 7 days post-infusion | 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 | From infusion to 7 days post-infusion | 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. |
Countries
United States
Contacts
CONTACTNicole Jones
CONTACTMakenna Brown
PRINCIPAL_INVESTIGATOREben Rosenthal, MD
Vanderbilt University Medical Center
Outcome results
None listed