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RECRUITING
NCT05747625
PHASE1

(89Zr Panitumumab) With PET/CT for Diagnosing Metastases in Patients With Head and Neck Squamous Cell Carcinoma

Sponsor: Eben Rosenthal

View on ClinicalTrials.gov

Summary

The goal of this phase I clinical trial is to evaluate the usefulness of an imaging test (zirconium Zr89 panitumumab \[89Zr panitumumab\]) with positron emission tomography (PET)/computed tomography (CT) for diagnosing the spread of disease from where it first started (primary site) to other places in the body (metastasis) in patients with head and neck squamous cell carcinoma. Traditional PET/CT has a low positive predictive value for diagnosing metastatic disease in head and neck cancer. 89Zr panitumumab is an investigational imaging agent that contains radiolabeled anti-EGFR antibody which is overexpressed in head and neck cancer. The main question this study aims to answer is the sensitivity and specificity of 89Zr panitumumab for the detection of indeterminate metastatic lesions in head and neck cancer. Participants will receive 89Zr panitumumab infusion and undergo 89Zr panitumumab PET/CT 1 to 5 days after infusion. Participants will otherwise receive standard of care evaluation and treatment for their indeterminate lesions. Researchers will compare the 89Zr panitumumab to standard of care imaging modalities (magnetic resonance imaging (MRI), CT, and/or PET/CT).

Official title: Study Evaluating 89Zr Panitumumab for Assessment of Indeterminate Metastatic Lesions on 18F-FDG-PET/CT in Head and Neck Squamous Cell Carcinoma

Key Details

Gender

All

Age Range

19 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2023-05-09

Completion Date

2030-03-01

Last Updated

2025-12-19

Healthy Volunteers

No

Interventions

BIOLOGICAL

Panitumumab

Given IV

DRUG

Zirconium Zr 89 Panitumumab

Given IV

PROCEDURE

Positron Emission Tomography

Undergo PET/CT

PROCEDURE

Computed Tomography

Undergo PET/CT

OTHER

Electronic Health Record Review

Ancillary studies

Locations (1)

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, United States