EXPLORER PET/CT in Healthy Volunteers

NCT04110743 | Completed Results

• 1 other identifier: 1341792
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (3)

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.

Device: EXPLORER PET/CT

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.

Device: EXPLORER PET/CT

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.

Device: EXPLORER PET/CT

Interventions

EXPLORER PET/CT DEVICE

Intervention: PET/CT using different protocols

comparison PET images reconstructed using CT-based attenuation; delayed imaging acquisition; low FDG dose imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California, Davis

Sacramento, California, 95817, United States

Location

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr. Lorenzo Nardo
• Organization: University of California Davis

lnardo@ucdavis.edu

916-731-9004

Study Officials

• Lorenzo Nardo, MD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2019
• First Posted: October 1, 2019
• Study Start: June 19, 2019
• Primary Completion: February 6, 2020
• Study Completion: February 6, 2020
• Last Updated: November 21, 2024
• Results First Posted: November 21, 2024

Record last verified: 2023-08

Locations

US (1)