Pilot Study for PET/MR Imaging of Covid-19

Study Overview
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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.

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.

Official Title
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Pilot Study for Simultaneous PET-MR Imaging of Covid-19 Associated Neurological Complications Using a Brain Dedicated PET Insert

Conditions
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Brain Diseases, Covid19

Intervention / Treatment
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* Diagnostic Test: Injected radiotracer with PET Insert


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Whole body radiation dose in the last year of less than 5000 mrem determined via subject verbal history reporting Must be at least 21 years of age Deemed healthy to endure duration of imaging study as confirmed via study PI Proof of COVID-19 viral or antibody testing within the timeframe of >20 days but <=180 days prior to scan. Exclusion Criteria: History of non-MRI compatible surgeries, implants, or activities Pregnant or nursing History of allergic reactions to PET radiotracers (via patient verbal report and /or medical record review.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Covid-19 Negative/Uninfected Population<br>5 participants will be recruited, injected with radiopharmaceutical, and imaged on the 3T PETMR with PET insert. | Diagnostic Test: Injected radiotracer with PET Insert<br>* Informed consent will be obtained before beginning any study procedures. 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.<br>|
| Experimental: Covid-19 Positive/Infected Population<br>5 participants will be recruited, injected with radiopharmaceutical, and imaged on the 3T PETMR with PET insert. | Diagnostic Test: Injected radiotracer with PET Insert<br>* Informed consent will be obtained before beginning any study procedures. 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PET/MR | The key specific measurement is the resulting PET/MR image obtained from the single subject scan. | Up to 24 months |