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

• Status: Not yet recruiting
• Trial end date: 2030-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Michael Topf
• Treatments: Panitumumab

Criteria

Inclusion Criteria:

• Age >= 19 years

• Biopsy confirmed diagnosis of squamous cell carcinoma of the head and neck

• 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 squamous cell carcinoma (SCC) based on 18F-fluorodeoxyglucose (FDG)-PET/CT

• Hemoglobin >= 9gm/dL

• White blood cell count > 3000/mm^3

• Platelet count >= 100,000/mm^3

• Serum creatinine =< 1.5 times upper reference range

• Estimated glomerular filtration rate (eGFR) >= 60mL/min/1.73m^2

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

• History of infusion reactions to other monoclonal antibody therapies

• Pregnant (based on screening serum pregnancy test and day 0 urine pregnancy test administered before unlabeled panitumumab), or breastfeeding

• Magnesium or potassium lower than the normal institutional values

• Subjects receiving class IA (quinidine, procainamide) or class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents

• Subjects with a history or evidence of interstitial pneumonitis or pulmonary fibrosis

• Severe renal disease or anuria

• Known hypersensitivity to deferoxamine or any of its components