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EXPLORER PET/CT in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04110743
Recruitment Status : Recruiting
First Posted : October 1, 2019
Last Update Posted : September 16, 2020
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

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.

Condition or disease Intervention/treatment Phase
Healthy Device: EXPLORER PET/CT Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: EXPLORER PET/CT: A Pilot Evaluation in Healthy Volunteers
Actual Study Start Date : June 19, 2019
Estimated Primary Completion Date : July 19, 2021
Estimated Study Completion Date : July 19, 2021

Arm Intervention/treatment
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.
Device: EXPLORER PET/CT
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.
Device: EXPLORER PET/CT
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.
Device: EXPLORER PET/CT
Intervention: PET/CT using different protocols




Primary Outcome Measures :
  1. 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 BW= Body weight [ Time Frame: approximatively 12 hours ]
    To collect preliminary data regarding FDG biodistribution as a function of time. Time-activity curves will be created

  2. Coefficient of variation. SD/mean (Standard deviation divided by mean value) [ Time Frame: approximatively 3 hours ]
    To obtain preliminary data regarding low dose EXPLORER noise level

  3. Standardized Uptake Value [ Time Frame: approximatively 1 hour ]
    To collect preliminary data about total body FDG perfusion and early biodistribution. Time-activity curves will be created

  4. Standardized Uptake Value SUV(t)= C(t)/(ID/BW) C(t) is radioactivity measured from an image 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 BW= Body weight [ Time Frame: approximatively 2 hours ]

    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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04110743


Contacts
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Contact: Elizabeth Nash 916-731-9004 eanash@ucdavis.edu

Locations
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United States, California
University of California, Davis Recruiting
Sacramento, California, United States, 95817
Contact: Elizabeth Nash    916-731-9004    eanash@ucdavis.edu   
Sponsors and Collaborators
University of California, Davis
Investigators
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Principal Investigator: Lorenzo Nardo, MD University of California, Davis
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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT04110743    
Other Study ID Numbers: 1341792
First Posted: October 1, 2019    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No