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
Judy Nguyen, MD

Clinical Assistant Professor, Radiology - Rad/Nuclear Medicine

Vasu Divi, MD
Vasu Divi, MD

Associate Professor of Otolaryngology - Head & Neck Surgery (OHNS)

Nicholas Leeper
Nicholas Leeper

Professor of Surgery (Vascular Surgery) and of Medicine (Cardiovascular)

Fred M Baik, MD
Fred M Baik, MD

Assistant Professor of Otolaryngology - Head & Neck Surgery (OHNS)

Benjamin Lewis Franc
Benjamin Lewis Franc

Clinical Professor, Radiology - Rad/Nuclear Medicine

Farshad Moradi
Farshad Moradi

Clinical Associate Professor, Radiology - Rad/Nuclear Medicine

Saad A. Khan, MD
Saad A. Khan, MD

Assistant Professor of Medicine (Oncology)

Jagruti Shah

Clinical Associate Professor, Radiology - Rad/Nuclear Medicine

A. Dimitrios Colevas, MD
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
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

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