(89Zr Panitumumab) With PET/CT for Diagnosing Metastases in Patients With Head and Neck Squamous Cell Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Panitumumab, Zirconium Zr 89 Panitumumab, Positron Emission Tomography, Computed Tomography.
- Who it may be relevant to
- Registry 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. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Study Evaluating 89Zr Panitumumab for Assessment of Indeterminate Metastatic Lesions on 18F-FDG-PET/CT in Head and Neck Squamous Cell Carcinoma
Overview
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.
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
Primary outcome measures
- Sensitivity of zirconium Zr 89 panitumumab (89Zr-panitumumab [Time frame: Up to 7 years]
- Specificity of 89Zr-panitumumab [Time frame: Up to 7 years]
Secondary outcome measures (2)
- Sensitivity of 89Zr-panitumumab [Time frame: Up to 7 years]
- Specificity of 89Zr-panitumumab [Time frame: Up to 7 years]
Eligibility criteria
Inclusion criteria
- Age >= 19 years
- Biopsy confirmed diagnosis of squamous cell carcinoma of the head and neck
- Subjects diagnosed with any T stage, any subsite within the head and neck. Subjects with recurrent disease or a new primary will be allowed
- Must have evidence of indeterminate metastatic squamous cell carcinoma (SCC) based on 18F-fluorodeoxyglucose (FDG)-PET/CT or Primary SCC with suspicious Lymph Nodes on CT prior to surgical removal
- Hemoglobin >= 9gm/dL
- White blood cell count > 3000/mm\^3
- Platelet count >= 100,000/mm\^3
- Serum creatinine =< 1.5 times upper reference range
Exclusion criteria
- Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment
- History of infusion reactions to other monoclonal antibody therapies
- Pregnant (based on screening serum pregnancy test and day 0 urine pregnancy test administered before unlabeled panitumumab), or breastfeeding
- Magnesium or potassium lower than the normal institutional values
- Subjects receiving class IA (quinidine, procainamide) or class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents
- Subjects with a history or evidence of interstitial pneumonitis or pulmonary fibrosis
- Severe renal disease or anuria
- Known hypersensitivity to deferoxamine or any of its components
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Vanderbilt University/Ingram Cancer Center — Nashville
Identifiers
NCT: NCT05747625 · VICCHN2279 · NCI-2023-01365