Actively Recruiting
(89Zr Panitumumab) With PET/CT for Diagnosing Metastases in Patients With Head and Neck Squamous Cell Carcinoma
Led by Eben Rosenthal · Updated on 2026-05-08
60
Participants Needed
1
Research Sites
355 weeks
Total Duration
On this page
Sponsors
E
Eben Rosenthal
Lead Sponsor
V
Vanderbilt-Ingram Cancer Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
(89Zr Panitumumab) With PET/CT for Diagnosing Metastases in Patients With Head and Neck Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 19 years or older
- Biopsy confirmed diagnosis of squamous cell carcinoma of the head and neck
- Any T stage and any subsite within the head and neck, including recurrent disease or new primary
- Evidence of indeterminate metastatic squamous cell carcinoma based on 18F-FDG PET/CT or primary SCC with suspicious lymph nodes on CT before surgery
- Hemoglobin level of 9 gm/dL or higher
- White blood cell count greater than 3000/mm^3
- Platelet count of 100,000/mm^3 or higher
- Serum creatinine less than or equal to 1.5 times the upper reference range
You will not qualify if you...
- History of myocardial infarction, cerebrovascular accident, uncontrolled congestive heart failure, significant liver disease, or unstable angina within 6 months prior to enrollment
- History of infusion reactions to other monoclonal antibody therapies
- Pregnant or breastfeeding
- Magnesium or potassium levels lower than normal institutional values
- Use of class IA or class III antiarrhythmic agents
- History or evidence of interstitial pneumonitis or pulmonary fibrosis
- Severe renal disease or anuria
- Known hypersensitivity to deferoxamine or any of its components
AI-Screening
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Trial Site Locations
Total: 1 location
1
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
Research Team
N
Nicole Jones
CONTACT
K
Kyrionna Golliday
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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