(89Zr Panitumumab) With PET/CT for Diagnosing Metastases in Patients With Head and Neck Squamous Cell Carcinoma
NCT ID: NCT05747625
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
60 participants
INTERVENTIONAL
2023-05-09
2030-03-01
Brief Summary
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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
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\- 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
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Diagnostic (89Zr panitumumab PET/CT)
Patients receive panitumumab IV, 89Zr panitumumab IV, and undergo PET/CT on study
Panitumumab
Given IV
Zirconium Zr 89 Panitumumab
Given IV
Positron Emission Tomography
Undergo PET/CT
Computed Tomography
Undergo PET/CT
Electronic Health Record Review
Ancillary studies
Interventions
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Panitumumab
Given IV
Zirconium Zr 89 Panitumumab
Given IV
Positron Emission Tomography
Undergo PET/CT
Computed Tomography
Undergo PET/CT
Electronic Health Record Review
Ancillary studies
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
19 Years
ALL
No
Sponsors
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Vanderbilt-Ingram Cancer Center
OTHER
Vanderbilt University Medical Center
OTHER
Eben Rosenthal
OTHER
Responsible Party
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Eben Rosenthal
Barry and Amy Baker Professor and Chair
Principal Investigators
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Michael Topf, MD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University/Ingram Cancer Center
Locations
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Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States
Countries
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Central Contacts
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Facility Contacts
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Vanderbilt-Ingram Service for Timely Access
Role: primary
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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VICCHN2279
Identifier Type: -
Identifier Source: org_study_id
NCI-2023-01365
Identifier Type: REGISTRY
Identifier Source: secondary_id