Study Evaluating [18F]NOTA-ABY030 for Safety and Tolerability of Indeterminate Primary and/or Metastatic Disease in Head and Neck Squamous Cell Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cetuximab (EGFR inhibitor), 18F-NOTA-ABY-030, Positron Emission Tomography (PET).
- Who it may be relevant to
- Registry conditions: SCC - Squamous Cell Carcinoma, Radiotracer, Head and Neck Squamous Cell Carcinoma, Metastatic Head and Neck Squamous Cell Carcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Drug Cetuximab (EGFR inhibitor)
Given IV - Drug 18F-NOTA-ABY-030
Given Bolus Injection - Procedure Positron Emission Tomography (PET)
Undergo PET/CT
Primary outcome measures
- Assess number, grade and severity of adverse events to determine safety and tolerability of [18F]NOTA-ABY-030 in human subjects. [Time frame: From infusion to 7 days post-infusion]
Secondary outcome measures (2)
- Determination of the radiation dosimetry for [18F]NOTA-ABY-030 in human subjects. [Time frame: From infusion to 7 days post-infusion]
- 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 [Time frame: From infusion to 7 days post-infusion]
Eligibility criteria
Inclusion criteria
- 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
- Have acceptable lab values, including the following clinical results (if values are considered clinically significant per investigator, participants must be asymptomatic):
- Hemoglobin ≥ 9gm/dL
- White blood cell count > 3000/mm3
- Platelet count ≥ 100,000/mm3
- Serum creatinine ≤ 1.5 times upper reference range
- Potassium
- Magnesium
- Phosphorus
Exclusion criteria
- 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.
- Subjects with history or evidence of interstitial pneumonitis or pulmonary fibrosis.
- Severe renal disease or anuria.
- Participants presenting with a baseline QTcF interval > than 480 milliseconds.
- Those with an allergy to red meat, a history of tick bites, and alpha-gal syndrome will be given extra consideration.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Vanderbilt University Medical Center — Nashville
Identifiers
NCT: NCT07217028 · VICCHNP25055