Pilot Study for PET/MR Imaging of Covid-19

March 13, 2026 updated by: Stanford University

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94305
        • Stanford University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Image quality of PET/MR
Time Frame: Up to 24 months
The key specific measurement is that resulting PET/MR images are of high quality, with comparable or better resolution and noise than that seen in other published articles.
Up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: Craig Levin, M. Phil., PhD., Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2022

Primary Completion (Actual)

August 19, 2023

Study Completion (Actual)

September 20, 2023

Study Registration Dates

First Submitted

July 7, 2021

First Submitted That Met QC Criteria

July 7, 2021

First Posted (Actual)

July 8, 2021

Study Record Updates

Last Update Posted (Actual)

March 17, 2026

Last Update Submitted That Met QC Criteria

March 13, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-59616

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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