EXPLORER PET/CT in Healthy Volunteers

NCT ID: NCT04110743

Last Updated: 2024-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-19
• Study Completion Date: 2020-02-06

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

EXPLORER PET/CT

Intervention Type: DEVICE

Intervention: PET/CT using different protocols

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.

Group Type: OTHER

EXPLORER PET/CT

Intervention Type: DEVICE

Intervention: PET/CT using different protocols

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.

Group Type: OTHER

EXPLORER PET/CT

Intervention Type: DEVICE

Intervention: PET/CT using different protocols

Interventions

EXPLORER PET/CT

Intervention: PET/CT using different protocols

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lorenzo Nardo, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

University of California, Davis

Sacramento, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1341792

Identifier Type: -

Identifier Source: org_study_id