Actively Recruiting
Study Evaluating 89Zr Panitumumab for Assessment of Indeterminate Metastatic Lesions on 18F-FDG-PET/CT in Head and Neck Squamous Cell Carcinoma
Led by Eben Rosenthal · Updated on 2026-05-08
60
Participants Needed
1
Research Sites
156 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
Researchers are evaluating an imaging test called zirconium Zr89 panitumumab combined with PET/CT scans to detect the spread of head and neck squamous cell carcinoma to other parts of the body. This phase I trial aims to assess how well 89Zr panitumumab identifies uncertain metastatic lesions compared to standard imaging methods like MRI, CT, and 18F-FDG PET/CT. The study focuses on the sensitivity and specificity of this investigational imaging agent in diagnosing metastatic disease. Participants will receive intravenous infusions of panitumumab and 89Zr panitumumab, followed by a PET/CT scan within 1 to 5 days after the infusion. They will also undergo standard care evaluations and treatments for their suspected metastatic lesions. The study compares 89Zr panitumumab PET/CT results to those from usual imaging techniques to determine its diagnostic value. During the study, participants will have blood tests to check hemoglobin, white blood cell count, platelet count, and kidney function. Researchers will monitor the imaging results to measure sensitivity and specificity over up to seven years. The study also tracks how often invasive procedures like biopsies are chosen versus observation. Participants will be followed and evaluated for safety and diagnostic accuracy throughout the study period.
CONDITIONS
Brief 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 63 19 years
- 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 on 18F-FDG PET/CT or suspicious lymph nodes on CT prior to surgery
- Hemoglobin 63 9 gm/dL
- White blood cell count > 3000/mm^3
- Platelet count 63 100,000/mm^3
- Serum creatinine 64 1.5 times upper reference range
You will not qualify if you...
- Myocardial infarction, stroke, uncontrolled congestive heart failure, significant liver disease, or unstable angina within 6 months
- History of infusion reactions to monoclonal antibody therapies
- Pregnant or breastfeeding
- Magnesium or potassium below normal institutional values
- Taking 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 its components
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants receive panitumumab and zirconium Zr 89 panitumumab intravenously and undergo PET/CT scans to assess indeterminate metastatic lesions.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
Research Team
N
Nicole Jones
K
Kyrionna Golliday
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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