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

Description

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.

Conditions

Head and Neck Squamous Cell Carcinoma

Study Overview

Study Details

Study overview

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.

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

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

Condition
Head and Neck Squamous Cell Carcinoma
Intervention / Treatment

-

Contacts and Locations

Birmingham

UAB, Birmingham, Alabama, United States, 35249

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 1. Received an investigational drug within 30 days prior to the first dose of \[89Zr\]panitumumab.
  • 2. Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment.
  • 3. Previous HNSCC resection.
  • 4. History of infusion reactions to monoclonal antibody therapies.
  • 5. Pregnant or breast-feeding women.
  • 6. Magnesium (\<1.7 mg/dL) or potassium (\<3.6 mmol/L) lower than the normal institutional values.
  • 7. Subjects receiving Class I-A (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents.
  • 8. Subjects with a history or evidence of interstitial pneumonitis or pulmonary fibrosis.
  • 9. Severe renal disease or anuria (Creatinine within normal institutional limits OR Creatinine clearance ≥60 mL/min/1.73 m2 for patients with creatinine levels).
  • 10. Known hypersensitivity to panitumumab or any of its components.
  • 11. Weight over 350 lbs., due to the scanner bore size.
  • 12. Contraindication for MRI procedures (e.g. non-removable metal implants or certain tattoos).

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Alabama at Birmingham,

Suzanne Lapi, PhD, PRINCIPAL_INVESTIGATOR, University of Alabama at Birmingham

Study Record Dates

2026-03-31