Clinical Trial

(89Zr Panitumumab) With PET/CT for Diagnosing Metastases in Patients With Head and Neck Squamous Cell Carcinoma

Recruiting Phase 1
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Summary
The goal of this phase I clinical trial is to evaluate the usefulness of an imaging test (zirconium Zr89 panitumumab \[89Zr panitumumab\]) with positron emission tomography (PET)/computed tomography (CT) for diagnosing the spread of disease from where it first started (primary site) to other places in the body (metastasis) in patients with head and neck squamous cell carcinoma. Traditional PET/CT has a low positive predictive value for diagnosing metastatic disease in head and neck cancer. 89Zr panitumumab is an investigational imaging agent that contains radiolabeled anti-EGFR antibody which is overexpressed in head and neck cancer. The main question this study aims to answer is the sensitivity and specificity of 89Zr panitumumab for the detection of indeterminate metastatic lesions in head and neck cancer. Participants will receive 89Zr panitumumab infusion and undergo 89Zr panitumumab PET/CT 1 to 5 days after infusion. Participants will otherwise receive standard of care evaluation and treatment for their indeterminate lesions. Researchers will compare the 89Zr panitumumab to standard of care imaging modalities (magnetic resonance imaging (MRI), CT, and/or PET/CT).
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2023-02-16; most recent amendment 2026-05-06.
Status change: Not Yet Recruiting → Recruiting 2023-04-10
Trial Details
NCT Number NCT05747625
Lead Sponsor Eben Rosenthal
Collaborators: Vanderbilt-Ingram Cancer Center, Vanderbilt University Medical Center
Conditions Head and Neck Squamous Cell Carcinoma, Metastatic Head and Neck Squamous Cell Carcinoma, Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck
Enrollment 60 participants
Start Date 2023-05-09
Primary Completion 2027-02-28 (estimated)
Study Completion 2030-03-01 (estimated)
Updated on ClinicalTrials.gov 2026-05-08