Comparison of 89Zr Panitumumab and (18)F-Fluorodeoxyglucose to Identify Head and Neck Squamous Cell Carcinoma
University of Alabama at Birmingham
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.
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 and neck (HNSCC) that undergo surgery with curative intent compared to standard of care,18F-FDG. Enrolled subjects are clinically and radiographically node negative (cN0) based on the preoperative work-up, which includes a standard of care physical exam and evaluation of the pre-existing imaging data (CT or MRI scan, which may be collected before or during standard of care \[18F\]FDG imaging). Con…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 f…
Interventions
- Drug[89Zr]Panitumumab Tracer
All patients entered into the study will have \[89Zr\]Panitumumab-PET/MRI imaging.
Location
- UABBirmingham, Alabama