(89Zr Panitumumab) With PET/CT for Diagnosing Metastases in Patients With Head and Neck Squamous Cell Carcinoma
NCT05747625 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2026-05-08
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).
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
- 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
Sponsors & Collaborators
-
Vanderbilt-Ingram Cancer Center
collaborator OTHER -
Vanderbilt University Medical Center
collaborator OTHER -
Eben Rosenthal
lead OTHER
Principal Investigators
-
Michael Topf, MD · Vanderbilt University/Ingram Cancer Center
Study Design
- Allocation
- NA
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 19 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-05-09
- Primary Completion
- 2027-02-28
- Completion
- 2030-03-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
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