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

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).

Full Title of Study: “Phase II Study Evaluating Zr-Panitumumab for Assessment of Suspected Metastatic Lesions on 18F-FDG-PET/CT in Head and Neck Squamous Cell Carcinoma”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2024

Detailed 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

Interventions

  • Drug: 89Zr-panitumumab IV
    • Subjects will be given a bolus of 1.0 mCi (range 0.8 – 1.2 mCi) of 89Zr-panitumumab before undergoing further standard of care diagnostic evaluation of the lesions
  • Drug: Panitumumab
    • Panitumumab 30mg will be given orally

Arms, Groups and Cohorts

  • Active Comparator: panitumumab 30 mg
    • Subjects will be given a 30mg of panitumumab
  • Experimental: 89Zr-panitumumab IV
    • Subjects will be given 89Zr-panitumumab IV

Clinical Trial Outcome Measures

Primary Measures

  • Sensitivity and Specificity of 89Zr-panitumumab
    • Time Frame: Up to 1 year
    • The total number of head and neck squamous cell carcinoma-involved incidental lesions will be determined and correlated to the radiologically suspicious lesions identified by 89Zr-panitumumab using PET/CT imaging.

Secondary Measures

  • Sensitivity and Specificity 89Zr-panitumumab compared to standard of care 18F-FDG PET/CT imaging
    • Time Frame: Up to 1 year
    • The total number of head and neck squamous cell carcinoma-involved incidental lesions will be determined and correlated to the radiologically suspicious lesions identified by 18F-FDG using PET/CT imaging. The specificity and sensitivity of 89Zr-panitumumab will be compared to the specificity and sensitivity of 18F-FDG for identification of metastatic lesions.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Andrei Iagaru
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Andrei Iagaru, Professor of Radiology (Nuclear Medicine) – Stanford University
  • Overall Official(s)
    • Judy Nguyen, MD, Principal Investigator, Stanford Cancer Institute
  • Overall Contact(s)
    • Roan C Raymundo, BS, (650) 721-4071, rcraymun@stanford.edu

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