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

Sponsor: Andrei Iagaru

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05423197

Patient View

This study assesses the diagnostic utility of 89Zr-panitumumab in detecting metastatic lesions in HNSCC. It compares its sensitivity and specificity to 18F-FDG-PET/CT. Eligible participants are adults with confirmed HNSCC and recent 18F-FDG-PET/CT scans. Interventions include an IV bolus of 89Zr-panitumumab and oral panitumumab. Participants must meet specific health criteria.

Patient Parameters

Program Overview

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).

Description

PRIMARY OBJECTIVE(S):

  • Determine the sensitivity and specificity of 89Zr-panitumumab for the detection of suspected metastatic lesions

SECONDARY OBJECTIVE(S):

  • Compare sensitivity and specificity of 18F-FDG-PET/CT and 89Zr-panitumumab-PET/CT for detection of suspected metastatic lesions

Eligibility 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

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