NCT05747625

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

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Eben Rosenthal · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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).

Detailed description

PRIMARY OBJECTIVE: \- Determine the sensitivity and specificity of zirconium Zr 89 panitumumab (89Zrpanitumumab) for the detection of indeterminate metastatic lesions in head and neck squamous cell carcinoma. SECONDARY OBJECTIVE: \- Compare sensitivity and specificity of standard of care imaging modalities (magnetic resonance imaging \[MRI\], CT and/or fludeoxyglucose F-18 \[18F\]-PET/CT) to 89Zr-panitumumab-PET/CT for detection of indeterminate metastatic lesions in head and neck squamous cell carcinoma. EXPLORATORY OBJECTIVE: \- Determine rate of intervention (e.g., biopsy or other invasive procedures) versus (vs) non-intervention (e.g., serial imaging, observation) by treatment team in subjects with indeterminate metastatic lesions on standard of care imaging. OUTLINE: Patients receive panitumumab intravenously (IV), 89Zr panitumumab IV, and undergo PET/CT on study.

Conditions

• Head and Neck Squamous Cell Carcinoma
• Metastatic Head and Neck Squamous Cell Carcinoma
• Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-05-09
• Primary completion: 2027-02-28
• Completion: 2030-03-01
• First posted: 2023-02-28
• Last updated: 2025-12-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study