Recruiting
Early Phase 1

89Zr Panitumumab vs. (18)F-Fluorodeoxyglucose

Sponsor:

University of Alabama at Birmingham

Code:

NCT05183048

Conditions

Head and Neck Squamous Cell Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

[89Zr]Panitumumab Tracer

Study Details

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.

Conditions

Head and Neck Squamous Cell Carcinoma

Study ID

NCT05183048

Start date

Feb 20, 2023

Status verified date

Dec, 2025

Completion date

Feb, 2028

Anticipated

Primary completion date

Feb, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 \[89Zr\]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).

Study Design

Enrollment

14 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: [89Zr]panitumumab-PET/MRI patients

All study patients will receive \[89Zr\]Panitumumab-PET/MRI imaging.

Interventions

[89Zr]Panitumumab Tracer

All patients entered into the study will have \[89Zr\]Panitumumab-PET/MRI imaging.

Primary outcome measure

  • Image Quality [ Time Frame: 5-9 days prior to surgery ]

Central Contacts and Locations

Central contacts

Locations

UAB

Recruiting

Birmingham, Alabama, United States, 35249

Contacts

Principal Investigator:

Suzanne Lapi, PhD

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Dec 26, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2025-12-26.