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Completed

NCT Number: NCT04110743

EXPLORER PET/CT in Healthy Volunteers

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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Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Davis

Sacramento, California, 95817, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EXPLORER PET/CT

Device

Intervention: PET/CT using different protocols

Primary outcomes

  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; W= Body Weight; SUV is Correct UM

    Time frame: approximatively 12 hours for Arm 1 only

    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

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

    Time frame: approximatively 6 hours for Arm 1 only

    To obtain preliminary data regarding low dose EXPLORER noise level

  3. Standardized Uptake Value

    Time frame: approximatively 90 minutes

    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 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

    Time frame: approximatively 3 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.

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Official study title

EXPLORER PET/CT: A Pilot Evaluation in Healthy Volunteers

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 1, 2019
Registry last updated
Nov 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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