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Purpose

The primary goal of this project is to study the feasibility of a prototype brain-dedicated PET insert for an MR scanner for simultaneous acquisition of PET/MR images of metabolism and perfusion in Covid-19 negative and positive/once positive subjects. This study serves as a pilot study for establishing an imaging protocol for combined PET and MR derived functional information as well as MRI acquired anatomical information.

Conditions

Eligibility

Eligible Ages
Over 21 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  1. Whole body radiation dose in the last year of less than 5000 mrem determined via subject verbal history reporting 2. Must be at least 21 years of age 3. Deemed healthy to endure duration of imaging study as confirmed via study PI 4. Proof of COVID-19 viral or antibody testing within the timeframe of >20 days but <=180 days prior to scan.

Exclusion Criteria

  1. History of non-MRI compatible surgeries, implants, or activities 2. Pregnant or nursing 3. History of allergic reactions to PET radiotracers (via patient verbal report and /or medical record review.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Other
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Covid-19 Negative/Uninfected Population 		5 participants will be recruited, injected with radiopharmaceutical, and imaged on the 3T PETMR with PET insert.
  • Diagnostic Test: Injected radiotracer with PET Insert
    1. Informed consent will be obtained before beginning any study procedures. 2. Participants will receive a small quantity of an FDA approved radiotracer. The PET insert is placed within a 3T MRI scanner, where PET and MRI imaging will be completed.
Experimental
Covid-19 Positive/Infected Population 		5 participants will be recruited, injected with radiopharmaceutical, and imaged on the 3T PETMR with PET insert.
  • Diagnostic Test: Injected radiotracer with PET Insert
    1. Informed consent will be obtained before beginning any study procedures. 2. Participants will receive a small quantity of an FDA approved radiotracer. The PET insert is placed within a 3T MRI scanner, where PET and MRI imaging will be completed.

Recruiting Locations

More Details

NCT ID
NCT04954248
Status
Terminated
Sponsor
Stanford University

Detailed Description

This study is a non-randomized non-treatment study. The intention of this work is an assessment of the PET insert technology, and not, for example, to perform a treatment assessment or drug assessment. This work will actively recruit 10 individuals (5 Covid-19 negative and 5 Covid-19 previously positive in the last 180 days) to perform imaging of the brain with an FDA-approved radiotracer.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.