All Drugs and Chemicals

Fluorodeoxyglucose F18

Radiopharmaceuticals

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

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

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

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

Radiolabel for positron emission tomography / computed tomography (PET/CT) and computed tomography (PET/CT) imaging

F-18 FDG

Ga-68-DOTA-TATE

Scan using a regular medical care (IDE-exempt) Discovery 600 / 690 PET/CT scanner.

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

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

Andrei Iagaru

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.

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.

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

Comparison 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.

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.

Stanford University

Associate Professor of Radiology

Per protocol, only unanticipated adverse events were to be collected.

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/CT 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.

18F-FDG PET/MRI 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/CT 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.

68Ga-DOTA-TATE PET/MRI Scan

Baseline information reflects participation of the individual human participants. Individual human participants are present in multiple assessment groups ("arms" or "cohorts"), and to avoid over-representation of those participants, data is not reported by group.

Total Participants

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Most subjects participated in more than 1 treatment arm. In order to not have participants represented multiple times in Participant Flow, this information is provided only at the study level.

Aortic arch

Gluteal muscle

Gluteal fat

Cerebellum

Parotid Gland

Lung

Liver

Spleen

Not all scans at all body locations could be completed.

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

PET/CT and PET/MRI scans were conducted using radiotracer 18-FDG.

18-FDG PET/CT and PET/MRI

PET/CT and PET/MRI scans were conducted using radiotracer 68Ga DOTA-TATE.

68Ga DOTA-TATE PET/CT and PET/MRI

PET/CT vs PET/MRI Difference in Standardized Uptake Value Max (SUVmax), by Radiotracer

Participant Flow reflects participation of individual human participants. Individual participants are present in multiple assessment groups ("arms" or "cohorts").

Spots Global Cancer Trial Database for Comparison of PET/CT vs. PET/MRI Using 2 Radiopharmaceuticals

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial