Status:
NOT_YET_RECRUITING
89Zr-Panitumumab for Assessment of Suspected Metastatic Lesions on 18F-FDG-PET/CT in HNSCC
Lead Sponsor:
Stanford University
Conditions:
Head-and-neck Squamous Cell Carcinoma
Eligibility:
All Genders
19+ years
Phase:
PHASE2
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 specifici...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05423197
Start Date
June 1 2026
End Date
December 1 2027
Last Update
July 16 2025
Active Locations (1)
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1
Stanford Cancer Institute
San Francisco, California, United States, 94305