TheranosticTrials.org

Clinical Trial · NCT05183048

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

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.

Sponsor

University of Alabama at Birmingham

Phase

Early Phase 1

Contacts

Suzanne Lapi, PhD (PRINCIPAL_INVESTIGATOR)

Chase Bower (CONTACT)

charlesbower@uabmc.edu

205-645-4457

Sebastian Eady, BS (CONTACT)

smeady@uabmc.edu

204-996-2636

ClinicalTrials.gov

NCT05183048

Drug / Compound

FDG

Isotope(s):
Target(s):
  • Glucose Transport
Ligand Class: Small Molecules

panitumumab

Isotope(s):
Target(s):
  • EGFR
Ligand Class: Antibodies
Chelator: DFO

Eligibility

Inclusion

  • 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:
  • Biopsy-confirmed diagnosis of squamous cell carcinoma of the head and neck
  • White blood cell count ≥ 3000/mm3
  • Subjects are to be staged clinically and radiographically node negative (cN0)
  • alanine transaminase (ALT) (SGPT) 7-56 units/liter, aspartate aminotransferase (AST) (SGOT) 5-40 units/liter.
  • Hemoglobin ≥ 9 gm/dL
  • Planned standard of care surgery with curative intent for squamous cell carcinoma
  • Serum creatinine ≤ 1.5 times upper reference range
  • Subjects newly diagnosed with any T stage, any subsite within the head and neck that are scheduled to undergo surgical resection.
  • Platelet count ≥ 100,000/mm3

Exclusion

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