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EXPLORER PET/CT in Healthy Volunteers

EXPLORER PET/CT: A Pilot Evaluation in Healthy Volunteers

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04110743
Enrollment
30
Registered
2019-10-01
Start date
2019-06-19
Completion date
2020-02-06
Last updated
2024-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

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.

Interventions

Intervention: PET/CT using different protocols

Sponsors

University of California, Davis
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Men and women, 18 years of age or older * Willing and able to fast for at least 6 hours before and for the duration of the scan * Willing and able to lay motionless in a supine position for 60 and 20 minutes at separate timepoints. * Willing and able to give informed consent

Exclusion criteria

* No Primary Care Physician * Body weight \>240 kg * Allergy to iodine contrast (only for subjects enrolled in Arm 3) * Creatinine levels \> 1.5 mg/dL or estimated glomerular filtration rate (eGFR) \< 60 ml/minute (only for subjects enrolled in Arm 3) * Recent (1 month) contrast enhanced CT * Any known concomitant acute infection (including upper respiratory infection, genitourinary infections, etc. * History of metastatic or newly (last 5 years) diagnosed locally invasive cancer. * Chemotherapy in the last 5 years * Radiation therapy in the last 3 years * Major surgery within the last 6 months. * Pregnancy or breast-feeding * Diabetes * Fasting blood glucose level \> 160 mg/dL before administration of FDG * Prisoners * The standard MRI contraindications apply, including but not limited to: 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

Design outcomes

Primary

MeasureTime frameDescription
Coefficient of Variation. SD/Mean (Standard Deviation Divided by Mean Value)approximatively 6 hours for Arm 1 onlyTo obtain preliminary data regarding low dose EXPLORER noise level
Standardized Uptake Valueapproximatively 90 minutesTo collect preliminary data about total body FDG perfusion and early biodistribution. Time-activity curves will be created
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 UMapproximatively 12 hours for Arm 1 onlyTo collect preliminary data regarding FDG biodistribution in the organs listed as a function of time of 12 hours. Time-activity curves will be created
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 UMapproximatively 3 hoursTo 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
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
15
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
15
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
Total30

Baseline characteristics

CharacteristicDelayed Imaging AcquisitionLow FDG Dose ImagingTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
1 Participants0 Participants1 Participants
Age, Categorical
Between 18 and 65 years
14 Participants15 Participants29 Participants
Age, Continuous49.5 YEARS45.3 YEARS47.4 YEARS
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
15 Participants15 Participants30 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
8 Participants4 Participants12 Participants
Race (NIH/OMB)
White
7 Participants10 Participants17 Participants
Region of Enrollment
United States
15 participants15 participants30 participants
Sex: Female, Male
Female
9 Participants7 Participants16 Participants
Sex: Female, Male
Male
6 Participants8 Participants14 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 150 / 150 / 0
other
Total, other adverse events
0 / 150 / 150 / 0
serious
Total, serious adverse events
0 / 150 / 150 / 0

Outcome results

Primary

Coefficient of Variation. SD/Mean (Standard Deviation Divided by Mean Value)

To obtain preliminary data regarding low dose EXPLORER noise level

Time frame: approximatively 6 hours for Arm 1 only

ArmMeasureGroupValue (MEAN)Dispersion
Delayed Imaging AcquisitionCoefficient of Variation. SD/Mean (Standard Deviation Divided by Mean Value)Aorta60.5 coefficientStandard Deviation 14.8
Delayed Imaging AcquisitionCoefficient of Variation. SD/Mean (Standard Deviation Divided by Mean Value)Lungs140.1 coefficientStandard Deviation 8.1
Delayed Imaging AcquisitionCoefficient of Variation. SD/Mean (Standard Deviation Divided by Mean Value)Liver32.2 coefficientStandard Deviation 9
Delayed Imaging AcquisitionCoefficient of Variation. SD/Mean (Standard Deviation Divided by Mean Value)Spleen31.4 coefficientStandard Deviation 9.3
Delayed Imaging AcquisitionCoefficient of Variation. SD/Mean (Standard Deviation Divided by Mean Value)Kidneys64.4 coefficientStandard Deviation 18.4
Delayed Imaging AcquisitionCoefficient of Variation. SD/Mean (Standard Deviation Divided by Mean Value)Bone Marrow40.8 coefficientStandard Deviation 11.8
Delayed Imaging AcquisitionCoefficient of Variation. SD/Mean (Standard Deviation Divided by Mean Value)Skeletal Muscles53.0 coefficientStandard Deviation 18.8
Delayed Imaging AcquisitionCoefficient of Variation. SD/Mean (Standard Deviation Divided by Mean Value)Subcutaneous Fat88.6 coefficientStandard Deviation 24.8
Delayed Imaging AcquisitionCoefficient of Variation. SD/Mean (Standard Deviation Divided by Mean Value)Whole Brain54.5 coefficientStandard Deviation 8.1
Delayed Imaging AcquisitionCoefficient of Variation. SD/Mean (Standard Deviation Divided by Mean Value)Myocardium63.0 coefficientStandard Deviation 16.7
Primary

Standardized Uptake Value

To collect preliminary data about total body FDG perfusion and early biodistribution. Time-activity curves will be created

Time frame: approximatively 90 minutes

ArmMeasureGroupValue (MEAN)Dispersion
Delayed Imaging AcquisitionStandardized Uptake ValueAorta1.75 SUVStandard Deviation 0.34
Delayed Imaging AcquisitionStandardized Uptake ValueLungs0.62 SUVStandard Deviation 0.37
Delayed Imaging AcquisitionStandardized Uptake ValueLiver2.49 SUVStandard Deviation 0.44
Delayed Imaging AcquisitionStandardized Uptake ValueSpleen2.15 SUVStandard Deviation 0.4
Delayed Imaging AcquisitionStandardized Uptake ValueKidneys3.65 SUVStandard Deviation 1.85
Delayed Imaging AcquisitionStandardized Uptake ValueBone Marrow2.51 SUVStandard Deviation 0.44
Delayed Imaging AcquisitionStandardized Uptake ValueSkeletal Muscles0.70 SUVStandard Deviation 0.19
Delayed Imaging AcquisitionStandardized Uptake ValueSubcutaneous Fat0.19 SUVStandard Deviation 0.05
Delayed Imaging AcquisitionStandardized Uptake ValueWhole Brain9.88 SUVStandard Deviation 2.63
Delayed Imaging AcquisitionStandardized Uptake ValueMyocardium10.73 SUVStandard Deviation 4.92
Arm 2Standardized Uptake ValueSubcutaneous Fat0.19 SUVStandard Deviation 0.04
Arm 2Standardized Uptake ValueAorta0.88 SUVStandard Deviation 0.17
Arm 2Standardized Uptake ValueBone Marrow0.73 SUVStandard Deviation 0.15
Arm 2Standardized Uptake ValueLungs0.32 SUVStandard Deviation 0.06
Arm 2Standardized Uptake ValueMyocardium1.20 SUVStandard Deviation 0.8
Arm 2Standardized Uptake ValueLiver1.02 SUVStandard Deviation 0.19
Arm 2Standardized Uptake ValueSkeletal Muscles0.37 SUVStandard Deviation 0.06
Arm 2Standardized Uptake ValueSpleen0.83 SUVStandard Deviation 0.15
Arm 2Standardized Uptake ValueWhole Brain4.95 SUVStandard Deviation 1.36
Arm 2Standardized Uptake ValueKidneys1.45 SUVStandard Deviation 0.23
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

Time frame: approximatively 12 hours for Arm 1 only

ArmMeasureGroupValue (MEAN)Dispersion
Delayed Imaging AcquisitionStandardized 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 UMAorta0.83 SUVStandard Deviation 0.47
Delayed Imaging AcquisitionStandardized 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 UMLungs0.48 SUVStandard Deviation 0.44
Delayed Imaging AcquisitionStandardized 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 UMLiver1.68 SUVStandard Deviation 0.51
Delayed Imaging AcquisitionStandardized 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 UMSpleen2.01 SUVStandard Deviation 0.49
Delayed Imaging AcquisitionStandardized 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 UMKidneys1.91 SUVStandard Deviation 0.83
Delayed Imaging AcquisitionStandardized 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 UMBone Marrow3.44 SUVStandard Deviation 0.85
Delayed Imaging AcquisitionStandardized 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 UMSkeletal Muscles1.23 SUVStandard Deviation 0.44
Delayed Imaging AcquisitionStandardized 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 UMSubcutaneous Fat0.25 SUVStandard Deviation 0.21
Delayed Imaging AcquisitionStandardized 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 UMWhole Brain5.81 SUVStandard Deviation 1.87
Delayed Imaging AcquisitionStandardized 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 UMMyocardium14.0 SUVStandard Deviation 6.93
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.

Time frame: approximatively 3 hours

ArmMeasureGroupValue (MEAN)Dispersion
Delayed Imaging AcquisitionStandardized 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 UMAorta1.18 SUVStandard Deviation 0.3
Delayed Imaging AcquisitionStandardized 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 UMLungs0.52 SUVStandard Deviation 0.53
Delayed Imaging AcquisitionStandardized 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 UMLiver2.11 SUVStandard Deviation 0.42
Delayed Imaging AcquisitionStandardized 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 UMSpleen2.09 SUVStandard Deviation 0.41
Delayed Imaging AcquisitionStandardized 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 UMKidneys3.30 SUVStandard Deviation 1.34
Delayed Imaging AcquisitionStandardized 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 UMBone Marrow2.92 SUVStandard Deviation 0.56
Delayed Imaging AcquisitionStandardized 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 UMSkeletal Muscles0.82 SUVStandard Deviation 0.21
Delayed Imaging AcquisitionStandardized 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 UMSubcutaneous Fat0.16 SUVStandard Deviation 0.05
Delayed Imaging AcquisitionStandardized 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 UMWhole Brain10.39 SUVStandard Deviation 3.02
Delayed Imaging AcquisitionStandardized 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 UMMyocardium11.60 SUVStandard Deviation 5.92
Arm 2Standardized 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 UMSubcutaneous Fat0.07 SUVStandard Deviation 0.02
Arm 2Standardized 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 UMAorta0.39 SUVStandard Deviation 0.08
Arm 2Standardized 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 UMBone Marrow0.44 SUVStandard Deviation 0.09
Arm 2Standardized 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 UMLungs0.15 SUVStandard Deviation 0.04
Arm 2Standardized 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 UMMyocardium0.68 SUVStandard Deviation 0.59
Arm 2Standardized 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 UMLiver0.50 SUVStandard Deviation 0.1
Arm 2Standardized 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 UMSkeletal Muscles0.21 SUVStandard Deviation 0.04
Arm 2Standardized 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 UMSpleen0.43 SUVStandard Deviation 0.08
Arm 2Standardized 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 UMWhole Brain2.97 SUVStandard Deviation 0.86
Arm 2Standardized 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 UMKidneys0.66 SUVStandard Deviation 0.12

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026