Pilot Study for PET/MR Imaging of Covid-19

NCT04954248 | Terminated DMC FDA Device

• 1 other identifier: IRB-59616
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19; Brain Diseases

Outcome Measures

Primary Outcomes (1)

• Image quality of PET/MR

  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

Study Arms (2)

Covid-19 Negative/Uninfected Population

EXPERIMENTAL

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

Diagnostic Test: Injected radiotracer with PET Insert

Covid-19 Positive/Infected Population

EXPERIMENTAL

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

Diagnostic Test: Injected radiotracer with PET Insert

Interventions

Injected radiotracer with PET Insert 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 Negative/Uninfected Population; Covid-19 Positive/Infected Population

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Palo Alto, California, 94305, United States

Location

MeSH Terms

Conditions

Brain Diseases; COVID-19

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Craig Levin, M. Phil., PhD.

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2021
• First Posted: July 8, 2021
• Study Start: July 1, 2022
• Primary Completion: August 19, 2023
• Study Completion: September 20, 2023
• Last Updated: March 17, 2026

Record last verified: 2026-03

Locations

US (1)