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

Head-and-neck Squamous Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05423197
• Other study ID #: IRB-63234
• Secondary ID: ENT0095
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 2024
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Stanford University
• Contact: Roan C Raymundo, BS
• Phone: (650) 721-4071
• Email: rcraymun[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Head-and-neck Squamous Cell Carcinoma
• Squamous Cell Carcinoma of Head and Neck

Intervention

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
• Panitumumab
Panitumumab 30mg will be given orally

Locations

Country	Name	City	State
United States	Stanford Cancer Institute	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Andrei Iagaru

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and Specificity of 89Zr-panitumumab	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.	Up to 1 year
Secondary	Sensitivity and Specificity 89Zr-panitumumab compared to standard of care 18F-FDG PET/CT imaging	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.	Up to 1 year