← Back to all trials
Not Yet Recruiting
NCT05747625
(89Zr Panitumumab) With PET/CT for Diagnosing Metastases in Patients With Head and Neck Squamous Cell Carcinoma
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 AJCC v8
Sex: All
Ages: 19 Years – N/A
Phase: PHASE1
Enrollment: 60
Sponsor: Michael Topf
Location: United States
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).
Eligibility Criteria
Inclusion Criteria:Age >= 19 yearsBiopsy confirmed diagnosis of squamous cell carcinoma of the head and neckSubjects diagnosed with any T stage, any subsite within the head and neck.
Subjects with recurrent disease or a new primary will be allowedMust have evidence of indeterminate metastatic squamous cell carcinoma (SCC) based on 18F-fluorodeoxyglucose (FDG)-PET/CTHemoglobin >= 9gm/dLWhite blood cell count > 3000/mm^3Platelet count >= 100,000/mm^3Serum creatinine =< 1.5 times upper reference rangeEstimated glomerular filtration rate (eGFR) >= 60mL/min/1.73m^2Exclusion Criteria:Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollmentHistory of infusion reactions to other monoclonal antibody therapiesPregnant (based on screening serum pregnancy test and day 0 urine pregnancy test administered before unlabeled panitumumab), or breastfeedingMagnesium or potassium lower than the normal institutional valuesSubjects receiving class IA (quinidine, procainamide) or class III (dofetilide, amiodarone, sotalol) antiarrhythmic agentsSubjects with a history or evidence of interstitial pneumonitis or pulmonary fibrosisSevere renal disease or anuriaKnown hypersensitivity to deferoxamine or any of its components
Source: ClinicalTrials.gov (NCT05747625). StuddyBuddy aggregates publicly available trial information.