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Clinical Trials/NCT03125629
NCT03125629
Completed
Phase 2

Comparison of PET/CT vs. PET/MRI

Stanford University1 site in 1 country53 target enrollmentMay 27, 2014

Overview

Phase
Phase 2
Intervention
F-18 FDG
Conditions
Cancer Diagnosis
Sponsor
Stanford University
Enrollment
53
Locations
1
Primary Endpoint
Absolute Accuracy of SUV Max of PET/CT vs PET/MRI
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

This clinical trial studies how well positron emission tomography (PET)/computed tomography (CT) works compared to PET/magnetic resonance imaging (MRI) in evaluating patients with cancer. PET/CT and PET/MRI may determine which scanner is best for the patient's type of cancer and other types of cancers.

Detailed Description

PRIMARY OBJECTIVES: 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.

Registry
clinicaltrials.gov
Start Date
May 27, 2014
End Date
February 5, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Andrei Iagaru

Associate Professor of Radiology

Stanford University

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

18F-FDG PET/MRI Scan

Participants will undergo a PET/MRI scan with radiolabel 18F-FDG.

Intervention: F-18 FDG

18F-FDG PET/CT Scan

Participants will undergo a PET/CT scan with radiolabel 18F-FDG.

Intervention: F-18 FDG

18F-FDG PET/CT Scan

Participants will undergo a PET/CT scan with radiolabel 18F-FDG.

Intervention: Positron Emission Tomography / Computed Tomography (PET/CT) Scan

18F-FDG PET/MRI Scan

Participants will undergo a PET/MRI scan with radiolabel 18F-FDG.

Intervention: Positron Emission Tomography / Magnetic Resonance Imaging (PET/MRI) Scan

68Ga-DOTA-TATE PET/CT Scan

Participants will undergo a PET/CT scan with radiolabel 68Ga-DOTA-TATE.

Intervention: Ga-68-DOTA-TATE

68Ga-DOTA-TATE PET/CT Scan

Participants will undergo a PET/CT scan with radiolabel 68Ga-DOTA-TATE.

Intervention: Positron Emission Tomography / Computed Tomography (PET/CT) Scan

68Ga-DOTA-TATE PET/MRI Scan

Participants will undergo a PET/MRI scan with radiolabel 68Ga-DOTA-TATE.

Intervention: Ga-68-DOTA-TATE

68Ga-DOTA-TATE PET/MRI Scan

Participants will undergo a PET/MRI scan with radiolabel 68Ga-DOTA-TATE.

Intervention: Positron Emission Tomography / Magnetic Resonance Imaging (PET/MRI) Scan

Outcomes

Primary Outcomes

Absolute Accuracy of SUV Max of PET/CT vs PET/MRI

Time Frame: 4 hours

Standardized uptake value max (SUVmax) is a measurement of the maximum radiopharmaceutical uptake value within the region of interest (ROI). SUVmax is calculated as the ratio of activity concentration:injected dose/body weight. The outcome is reported as the mean SUVmax with standard deviation (SD), reported for 8 specific organs or bodily locations.

Secondary Outcomes

  • PET/CT vs PET/MRI Difference in Standardized Uptake Value Max (SUVmax), by Radiotracer(estimated average of 2 hours)

Study Sites (1)

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