Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2017-00364 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| VARIMG0004 | Other Identifier | OnCore |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 18F-FDG PET/CT Scan | Experimental | Participants will undergo a PET/CT scan with radiolabel 18F-FDG. |
|
| 18F-FDG PET/MRI Scan | Experimental | Participants will undergo a PET/MRI scan with radiolabel 18F-FDG. |
|
| 68Ga-DOTA-TATE PET/CT Scan | Experimental | Participants will undergo a PET/CT scan with radiolabel 68Ga-DOTA-TATE. |
|
| 68Ga-DOTA-TATE PET/MRI Scan | Experimental | Participants will undergo a PET/MRI scan with radiolabel 68Ga-DOTA-TATE. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| F-18 FDG | Drug | Radiolabel for positron emission tomography / computed tomography (PET/CT) and computed tomography (PET/CT) imaging |
|
| 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 |
| 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. |
Not provided
INCLUSION CRITERIA
EXCLUSION CRITERIA
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Andrei Iagaru | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University, School of Medicine | Palo Alto | California | 94304 | United States |
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.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Total Participant Flow | Participant Flow reflects participation of individual human participants. Individual participants are present in multiple assessment groups ("arms" or "cohorts"). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 22, 2016 |
Not provided
All participants receive both scans.
Not provided
Not provided
Not provided
Not provided
| Ga-68-DOTA-TATE | Drug | Radiolabel for positron emission tomography / computed tomography (PET/CT) and computed tomography (PET/CT) imaging |
|
| Positron Emission Tomography / Computed Tomography (PET/CT) Scan | Device | Scan using a regular medical care (IDE-exempt) Discovery 600 / 690 PET/CT scanner. |
|
| Positron Emission Tomography / Magnetic Resonance Imaging (PET/MRI) Scan | Device | Scan using a NOVEL GE PET/MRI scanner. |
|
| estimated average of 2 hours |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Not all scans at all body locations could be completed. | Posted | Mean | Standard Deviation | ratio | 4 hours | scans | scans |
|
|
| |||||||||||||||||||||||||||
| 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. | Not all scans at all body locations could be completed. | Posted | Number | Percentage difference | estimated average of 2 hours | Scans (PET/CT + PET/MRI) | Scans (PET/CT + PET/MRI) |
|
1 day
Per protocol, only unanticipated adverse events were to be collected.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 18F-FDG PET/CT Scan | 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. | 0 | 44 | 0 | 44 | 0 | 44 |
| EG001 | 18F-FDG PET/MRI 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. | 0 | 42 | 0 | 42 | 0 | 42 |
| EG002 | 68Ga-DOTA-TATE PET/CT 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. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG003 | 68Ga-DOTA-TATE PET/MRI 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. | 0 | 6 | 0 | 6 | 0 | 6 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrei Iagaru | Stanford University | 650-725-4711 | aiagaru@stanford.edu |
| Nov 2, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| C513399 | gallium Ga 68 dotatate |
| D049268 | Positron-Emission Tomography |
| D014057 | Tomography, X-Ray Computed |
| D000072078 | Positron Emission Tomography Computed Tomography |
| D011877 | Radionuclide Imaging |
| D008279 | Magnetic Resonance Imaging |
| ID | Term |
|---|---|
| D014055 | Tomography, Emission-Computed |
| D007090 | Image Interpretation, Computer-Assisted |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D014054 | Tomography |
| D003947 | Diagnostic Techniques, Radioisotope |
| D011856 | Radiographic Image Enhancement |
| D011859 | Radiography |
| D014056 | Tomography, X-Ray |
| D064847 | Multimodal Imaging |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| scans |
|
|
| Gluteal muscle |
|
|
| Gluteal fat |
|
|
| Cerebellum |
|
|
| Parotid Gland |
|
|
| Lung |
|
|
| Liver |
|
|
| Spleen |
|
|
| Units | Counts |
|---|
| Participants |
|
| Scans (PET/CT + PET/MRI) |
|
|
|
|
|
|
|
|
|