Pilot Study for PET/MR Imaging of Covid-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2023-09-20

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Brain Diseases Covid19

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Covid-19 Negative/Uninfected Population

5 participants will be recruited, injected with radiopharmaceutical, and imaged on the 3T PETMR with PET insert.

Group Type EXPERIMENTAL

Injected radiotracer with PET Insert

Intervention Type DIAGNOSTIC_TEST

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.

Covid-19 Positive/Infected Population

5 participants will be recruited, injected with radiopharmaceutical, and imaged on the 3T PETMR with PET insert.

Group Type EXPERIMENTAL

Injected radiotracer with PET Insert

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes