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Study Evaluating Zr-Panitumumab for Assessment of Suspected Metastatic Lesions on 18F-FDG-PET/CT in Head and Neck Squamous Cell Carcinoma
Not Recruiting
Trial ID: NCT05423197
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
Stanford Investigator(s)
Judy Nguyen, MD
Clinical Assistant Professor, Radiology - Rad/Nuclear Medicine
Vasu Divi, MD
Associate Professor of Otolaryngology - Head & Neck Surgery (OHNS)
Nicholas Leeper
Professor of Surgery (Vascular Surgery) and of Medicine (Cardiovascular)
Fred M Baik, MD
Assistant Professor of Otolaryngology - Head & Neck Surgery (OHNS)
Benjamin Lewis Franc
Clinical Professor, Radiology - Rad/Nuclear Medicine
Farshad Moradi
Clinical Associate Professor, Radiology - Rad/Nuclear Medicine
Saad A. Khan, MD
Assistant Professor of Medicine (Oncology)
Jagruti Shah
Clinical Associate Professor, Radiology - Rad/Nuclear Medicine
A. Dimitrios Colevas, MD
Professor of Medicine (Oncology) and, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS) and of Radiation Oncology (Radiation Therapy)
Andrei Iagaru
Professor of Radiology (Nuclear Medicine)
Eligibility
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
Intervention(s):
drug: 89Zr-panitumumab IV
drug: Panitumumab
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Roan C Raymundo, BS
650-721-4071