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 iconNOT 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:
  1. * 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:
  2. * 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:
  1. * 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
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Investigator(s)

Judy Nguyen, MD
Judy Nguyen, MD
Radiologist
Clinical Assistant Professor, Radiology - Rad/Nuclear Medicine
Farshad Moradi
Farshad Moradi
Radiologist
Clinical Associate Professor, Radiology - Rad/Nuclear Medicine
Saad A. Khan, MD
Saad A. Khan, MD
Medical oncologist
Associate Professor of Medicine (Oncology)
Jagruti Shah
Clinical Associate Professor, Radiology - Rad/Nuclear Medicine
Fred M Baik, MD
Fred M Baik, MD
Head and neck surgeon, Surgical oncologist, Cutaneous oncology specialist
Assistant Professor of Otolaryngology - Head & Neck Surgery (OHNS)
Benjamin Lewis Franc
Benjamin Lewis Franc
Radiologist
Clinical Professor, Radiology - Rad/Nuclear Medicine
Nicholas Leeper
Nicholas Leeper
Cardiologist, Vascular medicine specialist
Professor of Surgery (Vascular Surgery) and of Medicine (Cardiovascular)
Vasu Divi, MD
Vasu Divi, MD
Head and neck surgeon, Surgical oncologist, Cutaneous oncology specialist
Associate Professor of Otolaryngology - Head & Neck Surgery (OHNS)
A. Dimitrios Colevas, MD
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)
Andrei Iagaru
Andrei Iagaru
Radiologist
Professor of Radiology (Nuclear Medicine)

Contact us to find out if this trial is right for you.

Contact

Roan C Raymundo, BS
650-721-4071

View on ClinicalTrials.gov