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The objective of this pilot study is to collect preliminary data using total body scans on a new, first of its kind, FDA 510k-cleared positron emission tomography/computed tomography (PET/CT) scanner, called EXPLORER.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| delayed imaging acquisition | Other | 10 mCi of 18F fluorodeoxyglucose (FDG) will be injected through the IV and a 60-minute dynamic scan will begin on EXPLORER. The IV line will be removed after dynamic acquisition. The dynamic scan will be preceded by ultra low-dose (1.298 mSv) CT scan to provide information for attenuation correction for the PET data. At 90 minutes, 3-, 6-, 9- and 12-hours, a static whole-body scan for 20 minutes will be acquired on EXPLORER. Prior to the 90-minute scan a low-dose CT (7.44 mSv) will be obtained both for anatomic localization and for attenuation correction purposes. Prior to each of the later time-points (3-, 6-, 9- and 12-hours), an ultra low-dose (1.298 mSv) CT scan will be acquired. This scan will be for attenuation correction purposes only. Following the 12-hour scan, the participant's study visit will be completed. MRI Brain will be also obtained after PET/CT scanning for anatomic correlation. |
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| low FDG dose imaging | Other | 0.5 mCi of 18F-FDG (1/20th of the standard dose) will be hand injected through the IV and a 60-minute dynamic scan will begin on EXPLORER. The dynamic scan will be preceded by an ultra-low-dose CT scan (1.298 mSv) for attenuation correction. The standard 20-minute EXPLORER scan obtained at 90 minutes will be obtained after a low dose CT (7.44 mSv) for attenuation and co-localization. The standard 20-minute EXPLORER scan obtained at 3 hours will be preceded by an ultra-low-dose CT scan (1.298 mSv) for attenuation correction only. MRI Brain will be also obtained after PET/CT scanning for anatomic correlation. |
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| comparison PET images reconstructed using CT-based attenuation | Other | 10 mCi of 18F-FDG will be hand injected through the IV and a 60-minute dynamic scan will begin on EXPLORER. Prior to the dynamic scan, an ultra-low-dose CT scan (1.298 mSv) will be acquired for attenuation correction purposes only. At 90 mins, a low dose non contrast enhancement CT (7.44 mSv) will be acquired vertex to toes. Iodinated contrast (150 cc of iodine Omnipaque 350) will then be intravenously injected (through the same IV placed to inject FDG) at 3 ml/sec while the patient remains still on the scanner and a second low-dose CT will be acquired. Finally, a 20-minute PET acquisition will be performed. The IV line will be removed after completion of the study. MRI Brain will be also obtained after PET/CT scanning for anatomic correlation. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EXPLORER PET/CT | Device | Intervention: PET/CT using different protocols |
|
| Measure | Description | Time Frame |
|---|---|---|
| Standardized Uptake Value SUV(t)= C(t)/ID/BW; C(t) is Radioactivity Measured at the Time t, Decay Corrected to t=0 and Converted From a Volume to a Mass Based Unit Via the Factor 1/(1 g/mL); ID: the Injected Dose at t=0; W= Body Weight; SUV is Correct UM | To collect preliminary data regarding FDG biodistribution in the organs listed as a function of time of 12 hours. Time-activity curves will be created | approximatively 12 hours for Arm 1 only |
| Coefficient of Variation. SD/Mean (Standard Deviation Divided by Mean Value) | To obtain preliminary data regarding low dose EXPLORER noise level | approximatively 6 hours for Arm 1 only |
| Standardized Uptake Value | To collect preliminary data about total body FDG perfusion and early biodistribution. Time-activity curves will be created | approximatively 90 minutes |
| Standardized Uptake Value SUV(t)= C(t)/(ID/BW); C(t) is Radioactivity Measured From at Time t, Decay Corrected to t=0-converted From a Volume to a Mass Based Unit Via the Factor 1/(1 g/mL); ID: the Injected Dose at t=0; BW= Body Weight; SUV is Correct UM | To obtain preliminary data to understand whether intravenous iodinated contrast agent produce a significant change in quantification of FDG uptake levels. Time/activity curves will be generated. | approximatively 3 hours |
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Inclusion Criteria:
Exclusion Criteria:
Having a pacemaker or other implanted electronic device. Metal foreign bodies, aneurysm clips, heart valve prosthesis, vascular stents, cochlear implants, embolization coils, gunshot wounds with retained bullet fragments, penile implant, IUCD.
Claustrophobia
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| Name | Affiliation | Role |
|---|---|---|
| Lorenzo Nardo, MD | University of California, Davis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Davis | Sacramento | California | 95817 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Delayed Imaging Acquisition | 10 mCi of 18F fluorodeoxyglucose (FDG) will be injected through the IV and a 60-minute dynamic scan will begin on EXPLORER. The IV line will be removed after dynamic acquisition. The dynamic scan will be preceded by ultra low-dose (1.298 mSv) CT scan to provide information for attenuation correction for the PET data. At 90 minutes, 3-, 6-, 9- and 12-hours, a static whole-body scan for 20 minutes will be acquired on EXPLORER. Prior to the 90-minute scan a low-dose CT (7.44 mSv) will be obtained both for anatomic localization and for attenuation correction purposes. Prior to each of the later time-points (3-, 6-, 9- and 12-hours), an ultra low-dose (1.298 mSv) CT scan will be acquired. This scan will be for attenuation correction purposes only. Following the 12-hour scan, the participant's study visit will be completed. MRI Brain will be also obtained after PET/CT scanning for anatomic correlation. EXPLORER PET/CT: Intervention: PET/CT using different protocols |
| FG001 | Low FDG Dose Imaging | 0.5 mCi of 18F-FDG (1/20th of the standard dose) will be hand injected through the IV and a 60-minute dynamic scan will begin on EXPLORER. The dynamic scan will be preceded by an ultra-low-dose CT scan (1.298 mSv) for attenuation correction. The standard 20-minute EXPLORER scan obtained at 90 minutes will be obtained after a low dose CT (7.44 mSv) for attenuation and co-localization. The standard 20-minute EXPLORER scan obtained at 3 hours will be preceded by an ultra-low-dose CT scan (1.298 mSv) for attenuation correction only. MRI Brain will be also obtained after PET/CT scanning for anatomic correlation. EXPLORER PET/CT: Intervention: PET/CT using different protocols |
| FG002 | Comparison PET Images Reconstructed Using CT-based Attenuation | 10 mCi of 18F-FDG will be hand injected through the IV and a 60-minute dynamic scan will begin on EXPLORER. Prior to the dynamic scan, an ultra-low-dose CT scan (1.298 mSv) will be acquired for attenuation correction purposes only. At 90 mins, a low dose non contrast enhancement CT (7.44 mSv) will be acquired vertex to toes. Iodinated contrast (150 cc of iodine Omnipaque 350) will then be intravenously injected (through the same IV placed to inject FDG) at 3 ml/sec while the patient remains still on the scanner and a second low-dose CT will be acquired. Finally, a 20-minute PET acquisition will be performed. The IV line will be removed after completion of the study. MRI Brain will be also obtained after PET/CT scanning for anatomic correlation. EXPLORER PET/CT: Intervention: PET/CT using different protocols |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Arm 3 was not completed
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| ID | Title | Description |
|---|---|---|
| BG000 | Delayed Imaging Acquisition | 10 mCi of 18F fluorodeoxyglucose (FDG) will be injected through the IV and a 60-minute dynamic scan will begin on EXPLORER. The IV line will be removed after dynamic acquisition. The dynamic scan will be preceded by ultra low-dose (1.298 mSv) CT scan to provide information for attenuation correction for the PET data. At 90 minutes, 3-, 6-, 9- and 12-hours, a static whole-body scan for 20 minutes will be acquired on EXPLORER. Prior to the 90-minute scan a low-dose CT (7.44 mSv) will be obtained both for anatomic localization and for attenuation correction purposes. Prior to each of the later time-points (3-, 6-, 9- and 12-hours), an ultra low-dose (1.298 mSv) CT scan will be acquired. This scan will be for attenuation correction purposes only. Following the 12-hour scan, the participant's study visit will be completed. MRI Brain will be also obtained after PET/CT scanning for anatomic correlation. EXPLORER PET/CT: Intervention: PET/CT using different protocols |
| 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 |
| 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 | Standardized Uptake Value SUV(t)= C(t)/ID/BW; C(t) is Radioactivity Measured at the Time t, Decay Corrected to t=0 and Converted From a Volume to a Mass Based Unit Via the Factor 1/(1 g/mL); ID: the Injected Dose at t=0; W= Body Weight; SUV is Correct UM | To collect preliminary data regarding FDG biodistribution in the organs listed as a function of time of 12 hours. Time-activity curves will be created | Posted | Mean | Standard Deviation | SUV | approximatively 12 hours for Arm 1 only |
|
AEs were collected during the study protocol activity of the one appointment for approximately 3 hours at which time the subject was off study.
All participants were monitored for AEs and SAEs throughout their participation.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Delayed Imaging Acquisition | 10 mCi of 18F fluorodeoxyglucose (FDG) will be injected through the IV and a 60-minute dynamic scan will begin on EXPLORER. The IV line will be removed after dynamic acquisition. The dynamic scan will be preceded by ultra low-dose (1.298 mSv) CT scan to provide information for attenuation correction for the PET data. At 90 minutes, 3-, 6-, 9- and 12-hours, a static whole-body scan for 20 minutes will be acquired on EXPLORER. Prior to the 90-minute scan a low-dose CT (7.44 mSv) will be obtained both for anatomic localization and for attenuation correction purposes. Prior to each of the later time-points (3-, 6-, 9- and 12-hours), an ultra low-dose (1.298 mSv) CT scan will be acquired. This scan will be for attenuation correction purposes only. Following the 12-hour scan, the participant's study visit will be completed. MRI Brain will be also obtained after PET/CT scanning for anatomic correlation. EXPLORER PET/CT: Intervention: PET/CT using different protocols |
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Logistical limitations did not allow us to enroll in Arm 3. It was originally expected that a CT with contrast could be completed on the EXPLORER scanner. It was learned during study activation that it could not. an additional limitation was finding research staff to complete follow up data collection delaying in reporting of the results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lorenzo Nardo | University of California Davis | 916-731-9004 | lnardo@ucdavis.edu |
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| 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 | Jan 27, 2021 | Aug 29, 2023 | Prot_SAP_000.pdf |
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| BG001 | Low FDG Dose Imaging | 0.5 mCi of 18F-FDG (1/20th of the standard dose) will be hand injected through the IV and a 60-minute dynamic scan will begin on EXPLORER. The dynamic scan will be preceded by an ultra-low-dose CT scan (1.298 mSv) for attenuation correction. The standard 20-minute EXPLORER scan obtained at 90 minutes will be obtained after a low dose CT (7.44 mSv) for attenuation and co-localization. The standard 20-minute EXPLORER scan obtained at 3 hours will be preceded by an ultra-low-dose CT scan (1.298 mSv) for attenuation correction only. MRI Brain will be also obtained after PET/CT scanning for anatomic correlation. EXPLORER PET/CT: Intervention: PET/CT using different protocols |
| BG002 | Comparison PET Images Reconstructed Using CT-based Attenuation | 10 mCi of 18F-FDG will be hand injected through the IV and a 60-minute dynamic scan will begin on EXPLORER. Prior to the dynamic scan, an ultra-low-dose CT scan (1.298 mSv) will be acquired for attenuation correction purposes only. At 90 mins, a low dose non contrast enhancement CT (7.44 mSv) will be acquired vertex to toes. Iodinated contrast (150 cc of iodine Omnipaque 350) will then be intravenously injected (through the same IV placed to inject FDG) at 3 ml/sec while the patient remains still on the scanner and a second low-dose CT will be acquired. Finally, a 20-minute PET acquisition will be performed. The IV line will be removed after completion of the study. MRI Brain will be also obtained after PET/CT scanning for anatomic correlation. EXPLORER PET/CT: Intervention: PET/CT using different protocols |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Geometric Mean | Full Range | YEARS |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Coefficient of Variation. SD/Mean (Standard Deviation Divided by Mean Value) | To obtain preliminary data regarding low dose EXPLORER noise level | Posted | Mean | Standard Deviation | coefficient | approximatively 6 hours for Arm 1 only |
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| Primary | Standardized Uptake Value | To collect preliminary data about total body FDG perfusion and early biodistribution. Time-activity curves will be created | Posted | Mean | Standard Deviation | SUV | approximatively 90 minutes |
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| Primary | Standardized Uptake Value SUV(t)= C(t)/(ID/BW); C(t) is Radioactivity Measured From at Time t, Decay Corrected to t=0-converted From a Volume to a Mass Based Unit Via the Factor 1/(1 g/mL); ID: the Injected Dose at t=0; BW= Body Weight; SUV is Correct UM | To obtain preliminary data to understand whether intravenous iodinated contrast agent produce a significant change in quantification of FDG uptake levels. Time/activity curves will be generated. | Posted | Mean | Standard Deviation | SUV | approximatively 3 hours |
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| 0 |
| 15 |
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| 15 |
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| 15 |
| EG001 | Low FDG Dose Imaging | 0.5 mCi of 18F-FDG (1/20th of the standard dose) will be hand injected through the IV and a 60-minute dynamic scan will begin on EXPLORER. The dynamic scan will be preceded by an ultra-low-dose CT scan (1.298 mSv) for attenuation correction. The standard 20-minute EXPLORER scan obtained at 90 minutes will be obtained after a low dose CT (7.44 mSv) for attenuation and co-localization. The standard 20-minute EXPLORER scan obtained at 3 hours will be preceded by an ultra-low-dose CT scan (1.298 mSv) for attenuation correction only. MRI Brain will be also obtained after PET/CT scanning for anatomic correlation. EXPLORER PET/CT: Intervention: PET/CT using different protocols | 0 | 15 | 0 | 15 | 0 | 15 |
| EG002 | Comparison PET Images Reconstructed Using CT-based Attenuation | 10 mCi of 18F-FDG will be hand injected through the IV and a 60-minute dynamic scan will begin on EXPLORER. Prior to the dynamic scan, an ultra-low-dose CT scan (1.298 mSv) will be acquired for attenuation correction purposes only. At 90 mins, a low dose non contrast enhancement CT (7.44 mSv) will be acquired vertex to toes. Iodinated contrast (150 cc of iodine Omnipaque 350) will then be intravenously injected (through the same IV placed to inject FDG) at 3 ml/sec while the patient remains still on the scanner and a second low-dose CT will be acquired. Finally, a 20-minute PET acquisition will be performed. The IV line will be removed after completion of the study. MRI Brain will be also obtained after PET/CT scanning for anatomic correlation. EXPLORER PET/CT: Intervention: PET/CT using different protocols | 0 | 0 | 0 | 0 | 0 | 0 |
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| Spleen |
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| Spleen |
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| Skeletal Muscles |
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| Whole Brain |
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| Myocardium |
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| Liver |
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| Spleen |
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| Kidneys |
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| Bone Marrow |
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| Skeletal Muscles |
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| Subcutaneous Fat |
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| Whole Brain |
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| Myocardium |
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