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Panitumumab-IRDye800 and 89Zr-Panitumumab in Identifying Metastatic Lymph Nodes in Patients With Squamous Cell Head and Neck Cancer

Not Recruiting

Trial ID: NCT03733210

Age - 19 Years-N/A Condition - Head and Neck Cancers (H&N) Gender - All Accepting Healthy Volunteers - No

Purpose

This study evaluates how well panitumumab-IRDye800 and 89Zr-panitumumab work in identifying cancer that has spread to the lymph nodes in patients with squamous cell head and neck cancer. Panitumumab-IRDye800 is a drug that contains a dye molecule that fluoresces during surgery to indicate cancerous tissue. 89Zr-panitumumab is a drug that contains a small amount of radiation, which makes it visible in positron emission tomography (PET) scans. PET scans make detailed, computerized pictures of areas inside the body where the drug is used. Giving panitumumab IRDye800 and 89Zr panitumumab to patients with head and neck cancer may help doctors find metastatic lymph nodes better than current methods [positron emission tomography (PET); computed tomography (CT); magnetic imaging resonance (MRI), or combinations].

Official Title

Pilot Study Evaluating Panitumumab-IRDye800 and 89Zr-Panitumumab for Dual-Modality Imaging for Nodal Staging in Head and Neck Cancer

Eligibility


Inclusion Criteria:

   - 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 that are
   scheduled to undergo surgical resection. Subjects with recurrent disease or a new
   primary will be allowed.

   - Planned standard of care surgery with curative intent for squamous cell carcinoma.

   - Hemoglobin ≥ 9 gm/dL.

   - White blood cell count > 3000/mm³.

   - Platelet count ≥ 100,000/mm³.

   - Serum creatinine ≤ 1.5 times upper reference range.

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.

   - Previous bilateral neck dissection.

   - History of infusion reactions to 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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Intervention(s):

drug: Panitumumab-IRDye800

drug: Zirconium Zr-89 Panitumumab

device: Pinpoint IR IR9000 flourescence imaging system (FIS)

device: SPY-PHI IR9000 flourescence imaging system (FIS)

device: Explorer Air camera

device: PDE-NEO II camera

device: FIS-00 fluorescence imaging system (FIS)

device: Da Vinci Firefly Imaging System

device: IGP-ELVIS-v4 Macroscopic Specimen Imager

device: Vevo 3100 LAZR-X

device: Pearl Triology Imaging System

device: Odyssey CLx Imaging System

device: Leica fluorescence microscope

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Alexander Ayon Valencia
650-498-5185

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