Comparison of PET/CT vs. PET/MRI Using 2 Radiopharmaceuticals
- Conditions
- Diagnostic Techniques and ProceduresDiagnostic ImagingCancer Diagnosis
- Interventions
- Drug: Ga-68-DOTA-TATEDevice: Positron Emission Tomography / Computed Tomography (PET/CT) ScanDevice: 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
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 18F-FDG PET/CT Scan F-18 FDG Participants will undergo a PET/CT scan with radiolabel 18F-FDG. 18F-FDG PET/CT Scan Positron Emission Tomography / Computed Tomography (PET/CT) Scan Participants will undergo a PET/CT scan with radiolabel 18F-FDG. 18F-FDG PET/MRI Scan F-18 FDG Participants will undergo a PET/MRI scan with radiolabel 18F-FDG. 18F-FDG PET/MRI Scan Positron Emission Tomography / Magnetic Resonance Imaging (PET/MRI) Scan Participants will undergo a PET/MRI scan with radiolabel 18F-FDG. 68Ga-DOTA-TATE PET/CT Scan Ga-68-DOTA-TATE Participants will undergo a PET/CT scan with radiolabel 68Ga-DOTA-TATE. 68Ga-DOTA-TATE PET/CT Scan Positron Emission Tomography / Computed Tomography (PET/CT) Scan Participants will undergo a PET/CT scan with radiolabel 68Ga-DOTA-TATE. 68Ga-DOTA-TATE PET/MRI Scan Ga-68-DOTA-TATE Participants will undergo a PET/MRI scan with radiolabel 68Ga-DOTA-TATE. 68Ga-DOTA-TATE PET/MRI Scan Positron Emission Tomography / Magnetic Resonance Imaging (PET/MRI) Scan Participants will undergo a PET/MRI scan with radiolabel 68Ga-DOTA-TATE.
- Primary Outcome Measures
Name Time Method Absolute Accuracy of SUV Max of PET/CT vs PET/MRI 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 Outcome Measures
Name Time Method PET/CT vs PET/MRI Difference in Standardized Uptake Value Max (SUVmax), by Radiotracer estimated 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