Study Evaluating Zr-Panitumumab for Assessment of Suspected Metastatic Lesions on 18F-FDG-PET/CT in Head and Neck Squamous Cell Carcinoma
Trial ID or NCT#
NCT05423197
Status
NOT RECRUITING
Purpose
The purpose of this study is to determine the diagnostic utility of 89Zr-panitumumab to identify metastatic lesion(s) in subjects with head and neck squamous cell carcinoma (HNSCC).
Official Title
Phase II Study Evaluating Zr-Panitumumab for Assessment of Suspected Metastatic Lesions on 18F-FDG-PET/CT in Head and Neck Squamous Cell Carcinoma
Eligibility Criteria
Ages Eligible for Study: Older than 19 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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 standard of care 18F-FDG-PET/CT scan ≤ 30 days of Day 0 with suspected metastatic lesions. - Have acceptable hematological status, coagulation status, kidney function, and liver function including the following clinical results: - Hemoglobin ≥ 9gm/dL - White blood cell count > 3000/mm3 - Platelet count ≥ 100,000/mm3 - Serum creatinine ≤ 1.5 times upper reference range - PTT = 11.5 - 14.4 seconds - INR = 0.9 - 1.2
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 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
Investigator(s)
Vasu Divi, MD
Head and neck surgeon
Associate Professor of Otolaryngology - Head & Neck Surgery (OHNS)
Nicholas Leeper
Cardiologist,
Vascular medicine specialist
Professor of Surgery (Vascular Surgery) and of Medicine (Cardiovascular)
Fred M Baik, MD
Head and neck surgeon
Assistant Professor of Otolaryngology - Head & Neck Surgery (OHNS)
Jagruti Shah
Clinical Associate Professor, Radiology - Rad/Nuclear Medicine
A. Dimitrios Colevas, MD
Medical oncologist,
Head and neck specialist,
Cutaneous oncology specialist
Professor of Medicine (Oncology) and, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS) and of Radiation Oncology (Radiation Therapy)
Contact us to find out if this trial is right for you.
Contact
Roan C Raymundo, BS
650-721-4071
View on ClinicalTrials.gov
