Study Evaluating Zr-Panitumumab for Assessment of Suspected Metastatic Lesions on 18F-FDG-PET/CT in Head and Neck Squamous Cell Carcinoma

• Status: Not yet recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Andrei Iagaru
• Treatments: Panitumumab

Criteria

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