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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of PET/CT vs. PET/MRI

Conditions
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Cancer Diagnosis, Diagnostic Techniques and Procedures, Diagnostic Imaging

Intervention / Treatment
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* Drug: F-18 FDG
* Drug: Ga-68-DOTA-TATE
* Device: Positron Emission Tomography / Computed Tomography (PET/CT) Scan
* Device: Positron Emission Tomography / Magnetic Resonance Imaging (PET/MRI) Scan


Participation Criteria
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Eligibility Criteria
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INCLUSION CRITERIA Cancer diagnosis Capable of complying with study procedures Able to remain still for duration of imaging procedure (approximately 90 minutes total) Written informed consent EXCLUSION CRITERIA Pregnant or nursing Metallic implants Impaired renal function

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: All participants receive both scans.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 18F-FDG PET/CT Scan<br>Participants will undergo a PET/CT scan with radiolabel 18F-FDG. | Drug: F-18 FDG<br>* Radiolabel for positron emission tomography / computed tomography (PET/CT) and computed tomography (PET/CT) imaging<br>Device: Positron Emission Tomography / Computed Tomography (PET/CT) Scan<br>* Scan using a regular medical care (IDE-exempt) Discovery 600 / 690 PET/CT scanner.<br>|
| Experimental: 18F-FDG PET/MRI Scan<br>Participants will undergo a PET/MRI scan with radiolabel 18F-FDG. | Drug: F-18 FDG<br>* Radiolabel for positron emission tomography / computed tomography (PET/CT) and computed tomography (PET/CT) imaging<br>Device: Positron Emission Tomography / Magnetic Resonance Imaging (PET/MRI) Scan<br>* Scan using a NOVEL GE PET/MRI scanner.<br>|
| Experimental: 68Ga-DOTA-TATE PET/CT Scan<br>Participants will undergo a PET/CT scan with radiolabel 68Ga-DOTA-TATE. | Drug: Ga-68-DOTA-TATE<br>* Radiolabel for positron emission tomography / computed tomography (PET/CT) and computed tomography (PET/CT) imaging<br>Device: Positron Emission Tomography / Computed Tomography (PET/CT) Scan<br>* Scan using a regular medical care (IDE-exempt) Discovery 600 / 690 PET/CT scanner.<br>|
| Experimental: 68Ga-DOTA-TATE PET/MRI Scan<br>Participants will undergo a PET/MRI scan with radiolabel 68Ga-DOTA-TATE. | Drug: Ga-68-DOTA-TATE<br>* Radiolabel for positron emission tomography / computed tomography (PET/CT) and computed tomography (PET/CT) imaging<br>Device: Positron Emission Tomography / Magnetic Resonance Imaging (PET/MRI) Scan<br>* Scan using a NOVEL GE PET/MRI scanner.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute Accuracy of SUV Max of PET/CT vs PET/MRI | 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. | 4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PET/CT vs PET/MRI Difference in Standardized Uptake Value Max (SUVmax), by Radiotracer | 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. | estimated average of 2 hours |