Brain DiseasesNCT04954248
Pilot Study for PET/MR Imaging of Covid-19
A study testing Injected radiotracer with PET Insert in people with Brain Diseases and Covid19, run by Stanford University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Brain Diseases, Covid19
- What is being tested?
- Injected radiotracer with PET Insert
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2022to 20 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Brain Diseases, Covid19
- Being tested
- Injected radiotracer with PET Insert
- Medical subject headings
- Brain Diseases, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injected radiotracer with PET InsertDiagnostic test
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Covid-19 Negative/Uninfected Population | Experimental | 5 participants will be recruited, injected with radiopharmaceutical, and imaged on the 3T PETMR with PET insert. Receives: 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. Receives: Diagnostic Test: Injected radiotracer with PET Insert |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start1 Jul 2022
- Primary completion19 Aug 2023
- Study completion20 Sep 2023
Why it stopped: The associated funding source was ended, and the proposed duration of the study ended.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain DiseasesStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Craig Levin, M. Phil., PhD., Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04954248
- Sponsor's protocol ID
- IRB-59616
- Status last verified
- Mar 2026
- First submitted
- 7 Jul 2021
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study for Simultaneous PET-MR Imaging of Covid-19 Associated Neurological Complications Using a Brain Dedicated PET Insert
- ClinicalTrials.gov ID
- NCT04954248
- Acronym / sponsor ID
- IRB-59616
- Conditions
- Brain Diseases, Covid19
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The associated funding source was ended, and the proposed duration of the study ended.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 19 Aug 2023 (actual)
- Study completion
- 20 Sep 2023 (actual)
- First posted
- 8 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Covid-19 Negative/Uninfected Population | Experimental | Diagnostic Test: Injected radiotracer with PET Insert5 participants will be recruited, injected with radiopharmaceutical, and imaged on the 3T PETMR with PET insert. |
| Covid-19 Positive/Infected Population | Experimental | Diagnostic Test: Injected radiotracer with PET Insert5 participants will be recruited, injected with radiopharmaceutical, and imaged on the 3T PETMR with PET insert. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Injected radiotracer with PET Insert1. 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. | Diagnostic test | Covid-19 Negative/Uninfected Population, Covid-19 Positive/Infected Population |
Primary outcome
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.
Results and safety
The study was stopped early (reason given: The associated funding source was ended, and the proposed duration of the study ended.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Craig Levin, M. Phil., PhD. principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Injected radiotracer with PET Insert in people with Brain Diseases and Covid19, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The associated funding source was ended, and the proposed duration of the study ended.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Image quality of PET/MR (time frame: Up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.