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Comparison of PET/CT vs. PET/MRI Using 2 Radiopharmaceuticals

Phase 2
Completed
Conditions
Diagnostic Techniques and Procedures
Diagnostic Imaging
Cancer Diagnosis
Interventions
Drug: Ga-68-DOTA-TATE
Device: Positron Emission Tomography / Computed Tomography (PET/CT) Scan
Device: Positron Emission Tomography / Magnetic Resonance Imaging (PET/MRI) Scan
Registration Number
NCT03125629
Lead Sponsor
Stanford University
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
53
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
18F-FDG PET/CT ScanF-18 FDGParticipants will undergo a PET/CT scan with radiolabel 18F-FDG.
18F-FDG PET/CT ScanPositron Emission Tomography / Computed Tomography (PET/CT) ScanParticipants will undergo a PET/CT scan with radiolabel 18F-FDG.
18F-FDG PET/MRI ScanF-18 FDGParticipants will undergo a PET/MRI scan with radiolabel 18F-FDG.
18F-FDG PET/MRI ScanPositron Emission Tomography / Magnetic Resonance Imaging (PET/MRI) ScanParticipants will undergo a PET/MRI scan with radiolabel 18F-FDG.
68Ga-DOTA-TATE PET/CT ScanGa-68-DOTA-TATEParticipants will undergo a PET/CT scan with radiolabel 68Ga-DOTA-TATE.
68Ga-DOTA-TATE PET/CT ScanPositron Emission Tomography / Computed Tomography (PET/CT) ScanParticipants will undergo a PET/CT scan with radiolabel 68Ga-DOTA-TATE.
68Ga-DOTA-TATE PET/MRI ScanGa-68-DOTA-TATEParticipants will undergo a PET/MRI scan with radiolabel 68Ga-DOTA-TATE.
68Ga-DOTA-TATE PET/MRI ScanPositron Emission Tomography / Magnetic Resonance Imaging (PET/MRI) ScanParticipants will undergo a PET/MRI scan with radiolabel 68Ga-DOTA-TATE.
Primary Outcome Measures
NameTimeMethod
Absolute Accuracy of SUV Max of PET/CT vs PET/MRI4 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 Outcome Measures
NameTimeMethod
PET/CT vs PET/MRI Difference in Standardized Uptake Value Max (SUVmax), by Radiotracerestimated average of 2 hours

Standardized uptake value max (SUVmax) is a measurement of the maximum radiopharmaceutical uptake within the region of interest (ROI). Relative accuracy of a particular radiotracer in a particular tissue is determined by expressing the absolute accuracy (obtained in the primary outcome measure) in terms of percent difference between SUVmax values obtained from PET/CT and PET/MR.

Percentage difference is expressed as the difference of the means in SUVmax for the PET/CT and PET/MRI scan procedures for the particular radiotracer, divided by the mean between the values for the 2 scan procedures.

The closer the percent difference is to 0%, the better the agreement between the two scanners. The outcome is expressed as the percentage difference, a number without dispersion.

Trial Locations

Locations (1)

Stanford University, School of Medicine

🇺🇸

Palo Alto, California, United States

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