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

Phase 2

Not yet recruiting

• Conditions: Head-and-neck Squamous Cell Carcinoma
• Interventions: Drug: 89Zr-panitumumab IV; Drug: Panitumumab

• Registration Number: NCT05423197
• Lead Sponsor: Andrei Iagaru

Brief 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).

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

Study Timeline

• Study First Submitted: 2022-06-14
• Study First Submitted QC: 2022-06-14
• Study First Posted: 2022-06-21
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-29
• Last Update Posted: 2024-10-31
• Study Start: 2025-06
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
89Zr-panitumumab IV	89Zr-panitumumab IV	Subjects will be given 89Zr-panitumumab IV
panitumumab 30 mg	Panitumumab	Subjects will be given a 30mg of panitumumab

Primary Outcome Measures

Name	Time	Method
Sensitivity and Specificity of 89Zr-panitumumab	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 Outcome Measures

Name	Time	Method
Sensitivity and Specificity 89Zr-panitumumab compared to standard of care 18F-FDG PET/CT imaging	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.

Trial Locations

Locations (1)

Stanford Cancer Institute; 🇺🇸 San Francisco, California, United States