Gallium-68 Prostate Specific Membrane Antigen PET in Diagnosing Patients With Thyroid Cancer
NCT ID: NCT03463889
Last Updated: 2021-06-29
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
12 participants
INTERVENTIONAL
2018-03-19
2020-10-31
Brief Summary
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Detailed Description
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I. To determine the feasibility and utility of Gallium Ga 68-labeled PSMA-11 (68Ga-PSMA) PET imaging in patients with thyroid cancer.
SECONDARY OBJECTIVES:
I. To assess the correlation between targeted molecular uptake of 68Ga-PSMA PET in thyroid cancer compared to areas identified as tumor by radioiodine uptake (in well-differentiated cancers) or fludeoxyglucose F-18 (18F-FDG) uptake (in poorly differentiated and/or radioiodine-negative cancers).
II. To determine and compare the sensitivity and specificity of 68Ga-PSMA PET to (18F-FDG) PET and/or radioiodine scintigraphy.
TERTIARY OBJECTIVES:
I. To determine if 68Ga-PSMA PET uptake is related to tumor differentiation and PSMA staining in tissue pathology when available.
II. To determine the correlation between standardized uptake value maximum (SUVmax) of target thyroid cancer lesions on 68Ga-PSMA PET and serum thyroglobulin levels.
OUTLINE:
Participants receive 68Ga-PSMA intravenously (IV) over 1-2 minutes and then undergo PET/MRI 60 minutes after injection. Patients may undergo a second PET/MRI 2-6 months after completion of first scan.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Diagnostic (Gallium Ga 68-labeled PSMA-11, PET/MRI)
Participants receive 68Ga-PSMA IV over 1-2 minutes and then undergo PET/MRI 60 minutes after injection. Patients may undergo a second PET/MRI 2-6 months after completion of first scan.
Gallium Ga 68-labeled PSMA-11
Given IV
Magnetic Resonance Imaging
Undergo MRI in combination with PET
Positron Emission Tomography (PET)
Undergo PET in combination with MRI
Interventions
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Gallium Ga 68-labeled PSMA-11
Given IV
Magnetic Resonance Imaging
Undergo MRI in combination with PET
Positron Emission Tomography (PET)
Undergo PET in combination with MRI
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Whole body 18F-FDG PET/computed tomography (CT) or I-131 scintigraphy within the past 90 days of the scheduled 68Ga-PSMA PET demonstrating uptake
* Creatinine =\< 3.0 mg/dL
* Ability to understand a written informed consent document, and the willingness to sign it
Exclusion Criteria
* Patients who are unable to have placement of intravenous line access
* Pregnant or breastfeeding women
* Patients not capable of undergoing a PET/MRI study due to weight, claustrophobia, or inability to lie still for the duration of the exam
18 Years
ALL
No
Sponsors
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University of California, San Francisco
OTHER
Responsible Party
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Robert Flavell, MD, PhD
Asst Professor in Residence
Principal Investigators
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Robert Flavell, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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University of California, San Francisco
San Francisco, California, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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NCI-2018-00055
Identifier Type: REGISTRY
Identifier Source: secondary_id
172016
Identifier Type: -
Identifier Source: org_study_id
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