Pilot Study for PET/MR Imaging of Covid-19

Not Applicable

Recruiting

• Conditions: Brain Diseases; Covid19
• Interventions: Diagnostic Test: Injected radiotracer with PET Insert

• Registration Number: NCT04954248
• Lead Sponsor: Stanford University

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-07-07
• Study First Submitted QC: 2021-07-07
• Study First Posted: 2021-07-08
• Study Start: 2022-07-01
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-19
• Last Update Posted: 2023-08-22
• Primary Completion: 2024-08-31
• Study Completion: 2024-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Covid-19 Positive/Infected Population	Injected radiotracer with PET Insert	5 participants will be recruited, injected with radiopharmaceutical, and imaged on the 3T PETMR with PET insert.
Covid-19 Negative/Uninfected Population	Injected radiotracer with PET Insert	5 participants will be recruited, injected with radiopharmaceutical, and imaged on the 3T PETMR with PET insert.

Primary Outcome Measures

Name	Time	Method
PET/MR	Up to 24 months	The key specific measurement is the resulting PET/MR image obtained from the single subject scan.

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Palo Alto, California, United States