Back to resultsPilot Study for PET/MR Imaging of Covid-19
Primary Purpose
Brain Diseases, Covid19
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Injected radiotracer with PET Insert
Sponsored by
About this trial
This is an interventional other trial for Brain Diseases
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Stanford UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Covid-19 Negative/Uninfected Population
Covid-19 Positive/Infected Population
Arm Description
5 participants will be recruited, injected with radiopharmaceutical, and imaged on the 3T PETMR with PET insert.
5 participants will be recruited, injected with radiopharmaceutical, and imaged on the 3T PETMR with PET insert.
Outcomes
Primary Outcome Measures
PET/MR
The key specific measurement is the resulting PET/MR image obtained from the single subject scan.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04954248
Brief Title
Pilot Study for PET/MR Imaging of Covid-19
Official Title
Pilot Study for Simultaneous PET-MR Imaging of Covid-19 Associated Neurological Complications Using a Brain Dedicated PET Insert
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Diseases, Covid19
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Covid-19 Negative/Uninfected Population
Arm Type
Experimental
Arm Description
5 participants will be recruited, injected with radiopharmaceutical, and imaged on the 3T PETMR with PET insert.
Arm Title
Covid-19 Positive/Infected Population
Arm Type
Experimental
Arm Description
5 participants will be recruited, injected with radiopharmaceutical, and imaged on the 3T PETMR with PET insert.
Intervention Type
Diagnostic Test
Intervention Name(s)
Injected radiotracer with PET Insert
Intervention Description
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.
Primary Outcome Measure Information:
Title
PET/MR
Description
The key specific measurement is the resulting PET/MR image obtained from the single subject scan.
Time Frame
Up to 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marcus Lou
Phone
4158163957
Email
mlou002@stanford.edu
Facility Information:
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcus Lou
Phone
415-816-3957
Email
mlou002@stanford.edu
12. IPD Sharing Statement
Learn more about this trial
Pilot Study for PET/MR Imaging of Covid-19
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