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Recruiting EARLY_Phase 1 NCT05183048

Comparison of 89Zr Panitumumab and (18)F-Fluorodeoxyglucose to Identify Head and Neck Squamous Cell Carcinoma

Trial Parameters

Condition Head and Neck Squamous Cell Carcinoma
Sponsor University of Alabama at Birmingham
Study Type INTERVENTIONAL
Phase EARLY_Phase 1
Enrollment 14
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2023-02-20
Completion 2028-02
Interventions
[89Zr]Panitumumab Tracer

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 location of primary tumors compared to standard of care Fludeoxyglucose (18F-FDG) -PET/MRI in newly diagnosed patients with head and neck squamous cell carcinoma (HNSCC) who are undergoing surgical resection. This study is for imaging purposes only and is not a treatment study. The results of this study will not change the clinical treatment plan.

Eligibility Criteria

Inclusion Criteria: 1. Biopsy-confirmed diagnosis of squamous cell carcinoma of the head and neck 2. Subjects newly diagnosed with any T stage, any subsite within the head and neck that are scheduled to undergo surgical resection. 3. Subjects are to be staged clinically and radiographically node negative (cN0) 4. Planned standard of care surgery with curative intent for squamous cell carcinoma 5. Age \> 18 years 6. 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: 1. Hemoglobin ≥ 9 gm/dL 2. White blood cell count ≥ 3000/mm3 3. Platelet count ≥ 100,000/mm3 4. Serum creatinine ≤ 1.5 times upper reference range 5. alanine transaminase (ALT) (SGPT) 7-56 units/liter, aspartate aminotransferase (AST) (SGOT) 5-40 units/liter. Exclusion Criteria: 1. Received an investigational drug within 30 days prior to the first dose of \[89Zr\]panitumu

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