89Zr Panitumumab PET/CT Imaging for Head and Neck Cancer
Trial Summary
What is the purpose of this trial?
The goal of this phase I clinical trial is to evaluate the usefulness of an imaging test (zirconium Zr 89 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).
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are taking certain heart rhythm medications (like quinidine, procainamide, dofetilide, amiodarone, or sotalol), you may not be eligible to participate.
What data supports the effectiveness of the treatment 89Zr Panitumumab PET/CT Imaging for Head and Neck Cancer?
Is 89Zr-panitumumab safe for use in humans?
How is the drug 89Zr-panitumumab unique for head and neck cancer?
89Zr-panitumumab is unique because it combines a monoclonal antibody, panitumumab, with a radioactive element, zirconium-89, to create a PET imaging agent that targets the epidermal growth factor receptor (EGFR) in tumors. This allows for non-invasive imaging to assess EGFR expression, potentially helping to select patients who might benefit from targeted therapies and to monitor treatment response.12567
Research Team
Michael C. Topf
Principal Investigator
Vanderbilt University/Ingram Cancer Center
Eligibility Criteria
This trial is for adults over 19 with head and neck squamous cell carcinoma, who have indeterminate metastatic lesions as shown by PET/CT scans. They must have a certain level of hemoglobin, kidney function (eGFR), and platelet count. Excluded are those with recent severe heart conditions, renal disease, pulmonary issues, pregnant or breastfeeding women, or allergies to similar drugs.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive panitumumab IV, 89Zr panitumumab IV, and undergo PET/CT on study
Follow-up
Participants are monitored for sensitivity and specificity of 89Zr panitumumab for detection of metastatic lesions
Treatment Details
Interventions
- Positron Emission Tomography
- Zirconium Zr 89 Panitumumab
Find a Clinic Near You
Who Is Running the Clinical Trial?
Michael Topf
Lead Sponsor