An Investigational Scan (89Zr-Panitumumab PET/MRI) compared to [18F]FDG-PET/MRI for the Imaging of Head and Neck Squamous Cell Carcinoma in Patients Undergoing Surgery

Status: active

This phase I trial studies the effect of an investigational scan called 89Zr-panitumumab positron emission tomography/magnetic resonance imaging (PET/MRI) in comparison to standard imaging called [18F]FDG-PET/MRI in imaging head and neck squamous cell carcinoma (HNSCC) in patients undergoing surgery. PET is a procedure in which a small amount of a radioactive substance is injected into a vein, and a scanner is used to make detailed, computerized pictures of areas inside the body where the radioactive substance is used. MRI is a procedure in which radio waves and a powerful magnet linked to a computer are used to create detailed pictures of areas inside the body. These pictures can show the difference between normal and diseased tissue. 89Zr-panitumumab is an imaging agent that contains 89Zr (a radioactive type of zirconium) that is attached to panitumumab, a type of drug called a monoclonal antibody that binds to a protein that is present on tumor cells called EGFR. This allows tumor cells to be seen on PET/MRI scans. 89Zr-panitumumab PET/MRI may work better than standard [18F]FDG-PET/MRI at imaging HNSCC.

Inclusion Criteria

Biopsy-confirmed diagnosis of squamous cell carcinoma of the head and neck
Subjects newly diagnosed with any T stage, any subsite within the head and neck that are scheduled to undergo surgical resection
Subjects are to be staged clinically and radiographically node negative (cN0)
Planned standard of care surgery with curative intent for squamous cell carcinoma
Age > 18 years
Coagulation status (11 to 13.5 seconds. International normalized ratio [INR ] of 0.8 to 1.1)
Hemoglobin ≥ 9 gm/dL
White blood cell count ≥ 3000/mm^3
Platelet count ≥ 100,000/mm^3
Serum creatinine ≤1.5 times upper reference range
Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) 7-56 units/liter, aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) 5-40 units/liter

Exclusion Criteria

Received an investigational drug within 30 days prior to the first dose of [89Zr]panitumumab
Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment
Previous HNSCC resection
History of infusion reactions to monoclonal antibody therapies
Pregnant or breast-feeding women
Magnesium (< 1.7 mg/dL) or potassium (< 3.6 mmol/L) 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 (Creatinine within normal institutional limits OR Creatinine clearance ≥ 60 mL/min/1.73 m^2 for patients with creatinine levels)
Known hypersensitivity to panitumumab or any of its components
Weight over 350 lbs., due to the scanner bore size
Contraindication for MRI procedures (e.g. non-removable metal implants or certain tattoos)

PRIMARY OBJECTIVE:

I. Compare the tumor standardized uptake value (SUV) and tumor to background ratio (TBR) of zirconium Zr 89 panitumumab ([89Zr]panitumumab) and fludeoxyglucose F-18 (18F-FDG) during positron emission tomography (PET) scans of patients with HNSCC.

SECONDARY OBJECTIVE:

I. Determine the sensitivity and specificity of [89Zr]panitumumab for the identification of primary HNSCC.

OUTLINE:

Five to nine days prior to surgery, patients undergo standard care (SOC) FDG-PET/MRI (if not already completed), receive panitumumab intravenously (IV) over 10 minutes, followed 60 minutes later by [89Zr]panitumumab IV over 1 minute and undergo PET/MRI. Patients also receive [89Zr]panitumumab IV over 1 minute and undergo PET/MRI 3-5 days prior to surgery (2-4 days after first [89Zr]panitumumab PET/MRI). Patients then undergo standard of care surgical resection on study.

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An Investigational Scan (89Zr-Panitumumab PET/MRI) compared to [18F]FDG-PET/MRI for the Imaging of Head and Neck Squamous Cell Carcinoma in Patients Undergoing Surgery

Inclusion Criteria

Exclusion Criteria

United States

Alabama

Birmingham

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An Investigational Scan (89Zr-Panitumumab PET/MRI) compared to [18F]FDG-PET/MRI for the Imaging of Head and Neck Squamous Cell Carcinoma in Patients Undergoing Surgery

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