Status:
RECRUITING
Comparison of 89Zr Panitumumab and (18)F-Fluorodeoxyglucose to Identify Head and Neck Squamous Cell Carcinoma
Lead Sponsor:
University of Alabama at Birmingham
Conditions:
Head and Neck Squamous Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
This pilot clinical study will investigate if Zirconium-89 (89Zr) panitumumab- Positron Emission Tomography/ Magnetic Resonance Imaging (PET/MRI) imaging can more accurately determine size and locatio...
Detailed Description
The study is an open label, single center, non-randomized, pilot study to determine the efficacy of \[89Zr\]panitumumab to localize primary tumor in patients with squamous cell carcinoma of the head a...
Eligibility Criteria
Inclusion
- Biopsy-confirmed diagnosis of squamous cell carcinoma of the head and neck
- Subjects newly diagnosed with any T stage, any subsite within the head and neck that are scheduled to undergo surgical resection.
- Subjects are to be staged clinically and radiographically node negative (cN0)
- Planned standard of care surgery with curative intent for squamous cell carcinoma
- Age \> 18 years
- Have acceptable hematologic status, coagulation status (11 to 13.5 seconds. international normalized ratio (INR) of 0.8 to 1.1), kidney function, and liver function including the following clinical results:
- Hemoglobin ≥ 9 gm/dL
- White blood cell count ≥ 3000/mm3
- Platelet count ≥ 100,000/mm3
- Serum creatinine ≤ 1.5 times upper reference range
- alanine transaminase (ALT) (SGPT) 7-56 units/liter, aspartate aminotransferase (AST) (SGOT) 5-40 units/liter.
Exclusion
- Received an investigational drug within 30 days prior to the first dose of \[89Zr\]panitumumab.
- Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment.
- Previous HNSCC resection.
- History of infusion reactions to monoclonal antibody therapies.
- Pregnant or breast-feeding women.
- Magnesium (\<1.7 mg/dL) or potassium (\<3.6 mmol/L) lower than the normal institutional values.
- Subjects receiving Class I-A (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 (Creatinine within normal institutional limits OR Creatinine clearance ≥60 mL/min/1.73 m2 for patients with creatinine levels).
- Known hypersensitivity to panitumumab or any of its components.
- Weight over 350 lbs., due to the scanner bore size.
- Contraindication for MRI procedures (e.g. non-removable metal implants or certain tattoos).
Key Trial Info
Start Date :
February 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2028
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT05183048
Start Date
February 20 2023
End Date
February 1 2028
Last Update
December 26 2025
Active Locations (1)
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1
UAB
Birmingham, Alabama, United States, 35249