Study of [18F]NOTA-ABY030 for Head and Neck Squamous Cell Carcinoma

This study is looking at the safety and how well a new imaging agent, [18F]NOTA-ABY030, works in people with head and neck squamous cell carcinoma (HNSCC). This agent helps doctors see tumors better on PET/CT scans. You would first receive a dose of cetuximab (an EGFR inhibitor, a type of drug that targets cancer cells) through an IV, followed by an injection of [18F]NOTA-ABY030. Then, you would have PET/CT scans to see how the agent moves through your body and lights up any tumors. The main goal is to check for any side effects and how well your body tolerates [18F]NOTA-ABY030. This study is currently unclear on its recruitment status and plans to enroll 25 participants who are at least 18 years old and have been diagnosed with HNSCC, especially if their tumors are hard to identify with standard imaging.

Study design
This is a Phase I, single-institution, open-label study involving approximately 25 participants. It is not randomized, meaning all participants will receive the same interventions.
What's involved
You would receive an IV infusion of Cetuximab, a bolus injection of [18F]NOTA-ABY-030, and undergo PET/CT scans at specific times.
Compensation
Not stated in the trial record.
Follow-up
Your safety and tolerability will be assessed from the time of infusion up to 7 days post-infusion.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07217028

Study Evaluating [18F]NOTA-ABY030 for Safety and Tolerability of Indeterminate Primary and/or Metastatic Disease in Head and Neck Squamous Cell Carcinoma

Recruiting
PHASE1Ages 18+InterventionalSupportive care
Vanderbilt-Ingram Cancer Center
~25 participants
Updated 2026-05-11 on ClinicalTrials.gov
What's tested:Cetuximab (EGFR inhibitor)18F-NOTA-ABY-030Positron Emission Tomography (PET)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Assess number, grade and severity of adverse events to determine safety and tolerability of [18F]NOTA-ABY-030 in human subjects.
Measured over From infusion to 7 days post-infusion
SCC - Squamous Cell Carcinoma
Radiotracer
Head and Neck Squamous Cell Carcinoma
Metastatic Head and Neck Squamous Cell Carcinoma
1 sites across 1 states
Tennessee1
  • Eben Rosenthal, MD · PRINCIPAL_INVESTIGATOR · Vanderbilt University Medical Center

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  • 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.