Comparison of PET/CT vs. PET/MRI Using 2 Radiopharmaceuticals
NCT ID: NCT03125629
Last Updated: 2021-04-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
53 participants
INTERVENTIONAL
2014-05-27
2020-02-05
Brief Summary
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Detailed Description
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I. To evaluate if PET/CT and PET/MRI scanners provide equivalent results for evaluation of cancer patients.
OUTLINE:
Patients receive standard of care 18F-fludeoxyglucose (FDG) or Ga68-DOTA-TATE intravenously (IV). Within 45-60 minutes, patients then undergo PET/CT imaging immediately followed by PET/MRI. Each participant is to receive 18-FDG or 68Ga-DOTA-TATE only, no participant was to receive both radiotracers.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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18F-FDG PET/CT Scan
Participants will undergo a PET/CT scan with radiolabel 18F-FDG.
F-18 FDG
Radiolabel for positron emission tomography / computed tomography (PET/CT) and computed tomography (PET/CT) imaging
Positron Emission Tomography / Computed Tomography (PET/CT) Scan
Scan using a regular medical care (IDE-exempt) Discovery 600 / 690 PET/CT scanner.
18F-FDG PET/MRI Scan
Participants will undergo a PET/MRI scan with radiolabel 18F-FDG.
F-18 FDG
Radiolabel for positron emission tomography / computed tomography (PET/CT) and computed tomography (PET/CT) imaging
Positron Emission Tomography / Magnetic Resonance Imaging (PET/MRI) Scan
Scan using a NOVEL GE PET/MRI scanner.
68Ga-DOTA-TATE PET/CT Scan
Participants will undergo a PET/CT scan with radiolabel 68Ga-DOTA-TATE.
Ga-68-DOTA-TATE
Radiolabel for positron emission tomography / computed tomography (PET/CT) and computed tomography (PET/CT) imaging
Positron Emission Tomography / Computed Tomography (PET/CT) Scan
Scan using a regular medical care (IDE-exempt) Discovery 600 / 690 PET/CT scanner.
68Ga-DOTA-TATE PET/MRI Scan
Participants will undergo a PET/MRI scan with radiolabel 68Ga-DOTA-TATE.
Ga-68-DOTA-TATE
Radiolabel for positron emission tomography / computed tomography (PET/CT) and computed tomography (PET/CT) imaging
Positron Emission Tomography / Magnetic Resonance Imaging (PET/MRI) Scan
Scan using a NOVEL GE PET/MRI scanner.
Interventions
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F-18 FDG
Radiolabel for positron emission tomography / computed tomography (PET/CT) and computed tomography (PET/CT) imaging
Ga-68-DOTA-TATE
Radiolabel for positron emission tomography / computed tomography (PET/CT) and computed tomography (PET/CT) imaging
Positron Emission Tomography / Computed Tomography (PET/CT) Scan
Scan using a regular medical care (IDE-exempt) Discovery 600 / 690 PET/CT scanner.
Positron Emission Tomography / Magnetic Resonance Imaging (PET/MRI) Scan
Scan using a NOVEL GE PET/MRI scanner.
Eligibility Criteria
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Inclusion Criteria
* Capable of complying with study procedures
* Able to remain still for duration of imaging procedure (approximately 90 minutes total)
* Written informed consent
Exclusion Criteria
* Metallic implants
* Impaired renal function
18 Years
ALL
No
Sponsors
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Stanford University
OTHER
Responsible Party
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Andrei Iagaru
Associate Professor of Radiology
Principal Investigators
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Andrei Iagaru
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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Stanford University, School of Medicine
Palo Alto, 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-2017-00364
Identifier Type: REGISTRY
Identifier Source: secondary_id
VARIMG0004
Identifier Type: OTHER
Identifier Source: secondary_id
IRB-27398
Identifier Type: -
Identifier Source: org_study_id
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