Pilot Study for PET/MR Imaging of Covid-19

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04954248
• Other study ID #: IRB-59616
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: August 31, 2024

Study information

• Verified date: August 2023
• Source: Stanford University
• Contact: Marcus Lou
• Phone: 4158163957
• Email: mlou002[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Diseases
• COVID-19
• Covid19

Intervention

Diagnostic Test:
• Injected radiotracer with PET Insert
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.

Locations

Country	Name	City	State
United States	Stanford University	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PET/MR	The key specific measurement is the resulting PET/MR image obtained from the single subject scan.	Up to 24 months