Pilot Study for PET/MR Imaging of Covid-19

Stanford University

Status: Terminated

Conditions: Covid19; Brain Diseases

Treatments: Diagnostic Test: Injected radiotracer with PET Insert

Study type: Interventional

Funder types: Other

Identifiers

NCT04954248

IRB-59616

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3 patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3 participants in 2 patient groups

Covid-19 Negative/Uninfected Population

Experimental group

Description:

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

Treatment:

Diagnostic Test: Injected radiotracer with PET Insert

Covid-19 Positive/Infected Population

Experimental group

Description:

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

Treatment:

Diagnostic Test: Injected radiotracer with PET Insert