Cancer Diagnosis, Diagnostic Techniques and Procedures, Diagnostic Imaging
Conditions
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.
Interventions
DRUGF-18 FDG
Radiolabel for positron emission tomography / computed tomography (PET/CT) and computed tomography (PET/CT) imaging
DRUGGa-68-DOTA-TATE
Radiolabel for positron emission tomography / computed tomography (PET/CT) and computed tomography (PET/CT) imaging
DEVICEPositron Emission Tomography / Computed Tomography (PET/CT) Scan
Scan using a regular medical care (IDE-exempt) Discovery 600 / 690 PET/CT scanner.
DEVICEPositron Emission Tomography / Magnetic Resonance Imaging (PET/MRI) Scan
Scan using a NOVEL GE PET/MRI scanner.
Sponsors
Stanford University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
All participants receive both scans.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Total Participants 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. | 53 |
| Total | 53 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Equipment malfunction | 1 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Total Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 10 Participants |
| Age, Categorical Between 18 and 65 years | 43 Participants |
| Age, Continuous | 54.34 years STANDARD_DEVIATION 12.64 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 47 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 8 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) White | 39 Participants |
| Region of Enrollment United States | 53 Participants |
| Sex: Female, Male Female | 27 Participants |
| Sex: Female, Male Male | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 44 | 0 / 42 | 0 / 6 | 0 / 6 |
| other Total, other adverse events | 0 / 44 | 0 / 42 | 0 / 6 | 0 / 6 |
| serious Total, serious adverse events | 0 / 44 | 0 / 42 | 0 / 6 | 0 / 6 |
Outcome results
Primary
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.
Time frame: 4 hours
Population: Not all scans at all body locations could be completed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 18F-FDG PET/CT Scan | Absolute Accuracy of SUV Max of PET/CT vs PET/MRI | Cerebellum | 8.56 ratio | Standard Deviation 2.64 |
| 18F-FDG PET/CT Scan | Absolute Accuracy of SUV Max of PET/CT vs PET/MRI | Lung | 0.57 ratio | Standard Deviation 0.21 |
| 18F-FDG PET/CT Scan | Absolute Accuracy of SUV Max of PET/CT vs PET/MRI | Liver | 2.72 ratio | Standard Deviation 0.66 |
| 18F-FDG PET/CT Scan | Absolute Accuracy of SUV Max of PET/CT vs PET/MRI | Spleen | 2.18 ratio | Standard Deviation 0.82 |
| 18F-FDG PET/CT Scan | Absolute Accuracy of SUV Max of PET/CT vs PET/MRI | Aortic arch | 1.78 ratio | Standard Deviation 0.42 |
| 18F-FDG PET/CT Scan | Absolute Accuracy of SUV Max of PET/CT vs PET/MRI | Gluteal muscle | 0.79 ratio | Standard Deviation 0.2 |
| 18F-FDG PET/CT Scan | Absolute Accuracy of SUV Max of PET/CT vs PET/MRI | Gluteal fat | 0.27 ratio | Standard Deviation 0.1 |
| 18F-FDG PET/CT Scan | Absolute Accuracy of SUV Max of PET/CT vs PET/MRI | Parotid Gland | 1.71 ratio | Standard Deviation 0.68 |
| 18F-FDG PET/MRI Scan | Absolute Accuracy of SUV Max of PET/CT vs PET/MRI | Lung | 0.36 ratio | Standard Deviation 0.15 |
| 18F-FDG PET/MRI Scan | Absolute Accuracy of SUV Max of PET/CT vs PET/MRI | Liver | 2.21 ratio | Standard Deviation 0.59 |
| 18F-FDG PET/MRI Scan | Absolute Accuracy of SUV Max of PET/CT vs PET/MRI | Spleen | 2.03 ratio | Standard Deviation 0.97 |
| 18F-FDG PET/MRI Scan | Absolute Accuracy of SUV Max of PET/CT vs PET/MRI | Gluteal fat | 0.26 ratio | Standard Deviation 0.09 |
| 18F-FDG PET/MRI Scan | Absolute Accuracy of SUV Max of PET/CT vs PET/MRI | Aortic arch | 1.08 ratio | Standard Deviation 0.38 |
| 18F-FDG PET/MRI Scan | Absolute Accuracy of SUV Max of PET/CT vs PET/MRI | Gluteal muscle | 0.94 ratio | Standard Deviation 0.28 |
| 18F-FDG PET/MRI Scan | Absolute Accuracy of SUV Max of PET/CT vs PET/MRI | Cerebellum | 7.79 ratio | Standard Deviation 2.49 |
| 18F-FDG PET/MRI Scan | Absolute Accuracy of SUV Max of PET/CT vs PET/MRI | Parotid Gland | 1.76 ratio | Standard Deviation 0.77 |
| 68Ga-DOTA-TATE PET/CT Scan | Absolute Accuracy of SUV Max of PET/CT vs PET/MRI | Cerebellum | 0.22 ratio | Standard Deviation 0.09 |
| 68Ga-DOTA-TATE PET/CT Scan | Absolute Accuracy of SUV Max of PET/CT vs PET/MRI | Spleen | 13.07 ratio | Standard Deviation 3.75 |
| 68Ga-DOTA-TATE PET/CT Scan | Absolute Accuracy of SUV Max of PET/CT vs PET/MRI | Gluteal muscle | 0.42 ratio | Standard Deviation 0.19 |
| 68Ga-DOTA-TATE PET/CT Scan | Absolute Accuracy of SUV Max of PET/CT vs PET/MRI | Aortic arch | 0.54 ratio | Standard Deviation 0.22 |
| 68Ga-DOTA-TATE PET/CT Scan | Absolute Accuracy of SUV Max of PET/CT vs PET/MRI | Gluteal fat | 0.14 ratio | Standard Deviation 0.06 |
| 68Ga-DOTA-TATE PET/CT Scan | Absolute Accuracy of SUV Max of PET/CT vs PET/MRI | Parotid Gland | 1.28 ratio | Standard Deviation 0.6 |
| 68Ga-DOTA-TATE PET/CT Scan | Absolute Accuracy of SUV Max of PET/CT vs PET/MRI | Lung | 0.31 ratio | Standard Deviation 0.05 |
| 68Ga-DOTA-TATE PET/CT Scan | Absolute Accuracy of SUV Max of PET/CT vs PET/MRI | Liver | 9.47 ratio | Standard Deviation 7.15 |
| 68Ga-DOTA-TATE PET/MRI Scan | Absolute Accuracy of SUV Max of PET/CT vs PET/MRI | Gluteal fat | 0.24 ratio | Standard Deviation 0.07 |
| 68Ga-DOTA-TATE PET/MRI Scan | Absolute Accuracy of SUV Max of PET/CT vs PET/MRI | Liver | 10.86 ratio | Standard Deviation 7.6 |
| 68Ga-DOTA-TATE PET/MRI Scan | Absolute Accuracy of SUV Max of PET/CT vs PET/MRI | Spleen | 15.74 ratio | Standard Deviation 3.16 |
| 68Ga-DOTA-TATE PET/MRI Scan | Absolute Accuracy of SUV Max of PET/CT vs PET/MRI | Cerebellum | 0.12 ratio | Standard Deviation 0.12 |
| 68Ga-DOTA-TATE PET/MRI Scan | Absolute Accuracy of SUV Max of PET/CT vs PET/MRI | Lung | 0.26 ratio | Standard Deviation 0.2 |
| 68Ga-DOTA-TATE PET/MRI Scan | Absolute Accuracy of SUV Max of PET/CT vs PET/MRI | Gluteal muscle | 0.47 ratio | Standard Deviation 0.25 |
| 68Ga-DOTA-TATE PET/MRI Scan | Absolute Accuracy of SUV Max of PET/CT vs PET/MRI | Aortic arch | 0.51 ratio | Standard Deviation 0.19 |
| 68Ga-DOTA-TATE PET/MRI Scan | Absolute Accuracy of SUV Max of PET/CT vs PET/MRI | Parotid Gland | 1.06 ratio | Standard Deviation 0.26 |
Secondary
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.
Time frame: estimated average of 2 hours
Population: Not all scans at all body locations could be completed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 18F-FDG PET/CT Scan | PET/CT vs PET/MRI Difference in Standardized Uptake Value Max (SUVmax), by Radiotracer | Gluteal fat | 3.77 Percentage difference |
| 18F-FDG PET/CT Scan | PET/CT vs PET/MRI Difference in Standardized Uptake Value Max (SUVmax), by Radiotracer | Parotid Gland | 2.88 Percentage difference |
| 18F-FDG PET/CT Scan | PET/CT vs PET/MRI Difference in Standardized Uptake Value Max (SUVmax), by Radiotracer | Gluteal muscle | 17.34 Percentage difference |
| 18F-FDG PET/CT Scan | PET/CT vs PET/MRI Difference in Standardized Uptake Value Max (SUVmax), by Radiotracer | Lung | 45.16 Percentage difference |
| 18F-FDG PET/CT Scan | PET/CT vs PET/MRI Difference in Standardized Uptake Value Max (SUVmax), by Radiotracer | Cerebellum | 9.42 Percentage difference |
| 18F-FDG PET/CT Scan | PET/CT vs PET/MRI Difference in Standardized Uptake Value Max (SUVmax), by Radiotracer | Liver | 20.69 Percentage difference |
| 18F-FDG PET/CT Scan | PET/CT vs PET/MRI Difference in Standardized Uptake Value Max (SUVmax), by Radiotracer | Spleen | 7.13 Percentage difference |
| 18F-FDG PET/CT Scan | PET/CT vs PET/MRI Difference in Standardized Uptake Value Max (SUVmax), by Radiotracer | Aortic arch | 48.95 Percentage difference |
| 18F-FDG PET/MRI Scan | PET/CT vs PET/MRI Difference in Standardized Uptake Value Max (SUVmax), by Radiotracer | Spleen | 18.54 Percentage difference |
| 18F-FDG PET/MRI Scan | PET/CT vs PET/MRI Difference in Standardized Uptake Value Max (SUVmax), by Radiotracer | Aortic arch | 5.71 Percentage difference |
| 18F-FDG PET/MRI Scan | PET/CT vs PET/MRI Difference in Standardized Uptake Value Max (SUVmax), by Radiotracer | Gluteal muscle | 11.24 Percentage difference |
| 18F-FDG PET/MRI Scan | PET/CT vs PET/MRI Difference in Standardized Uptake Value Max (SUVmax), by Radiotracer | Gluteal fat | 52.63 Percentage difference |
| 18F-FDG PET/MRI Scan | PET/CT vs PET/MRI Difference in Standardized Uptake Value Max (SUVmax), by Radiotracer | Cerebellum | 58.82 Percentage difference |
| 18F-FDG PET/MRI Scan | PET/CT vs PET/MRI Difference in Standardized Uptake Value Max (SUVmax), by Radiotracer | Parotid Gland | 18.80 Percentage difference |
| 18F-FDG PET/MRI Scan | PET/CT vs PET/MRI Difference in Standardized Uptake Value Max (SUVmax), by Radiotracer | Lung | 17.54 Percentage difference |
| 18F-FDG PET/MRI Scan | PET/CT vs PET/MRI Difference in Standardized Uptake Value Max (SUVmax), by Radiotracer | Liver | 13.67 Percentage difference |