Actively Recruiting

Early Phase 1
Age: 18Years +
All Genders
NCT05183048

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

Led by University of Alabama at Birmingham · Updated on 2025-12-26

14

Participants Needed

1

Research Sites

258 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Biopsy-confirmed diagnosis of squamous cell carcinoma of the head and neck
  • Newly diagnosed patients with any T stage and any head and neck subsite who are scheduled for surgical resection
  • Clinically and radiographically node negative (cN0) based on preoperative evaluation
  • Planned standard of care surgery with curative intent for squamous cell carcinoma
  • Age over 18 years
  • Acceptable blood counts and organ function, including hemoglobin at least 9 gm/dL, white blood cell count at least 3000/mm3, platelet count at least 100,000/mm3, serum creatinine no greater than 1.5 times upper limit, ALT 7-56 units/liter, and AST 5-40 units/liter
Not Eligible

You will not qualify if you...

  • Received any investigational drug within 30 days before the first dose of 89Zr panitumumab
  • History of heart attack, stroke, uncontrolled heart failure, significant liver disease, or unstable angina within 6 months prior to enrollment
  • Previous surgery for head and neck squamous cell carcinoma
  • History of infusion reactions to monoclonal antibody therapies
  • Pregnant or breastfeeding women
  • Low magnesium (less than 1.7 mg/dL) or potassium (less than 3.6 mmol/L) levels
  • Currently taking Class I-A or Class III antiarrhythmic medications
  • History or evidence of interstitial pneumonitis or pulmonary fibrosis
  • Severe kidney disease or anuria
  • Known allergy to panitumumab or its components
  • Weight over 350 pounds due to scanner size limitations
  • Contraindications to MRI such as non-removable metal implants or certain tattoos

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

UAB

Birmingham, Alabama, United States, 35249

Actively Recruiting

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Research Team

S

Sebastian Eady, BS

CONTACT

C

Chase Bower

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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