60 Participants Needed

PET Imaging for Post-COVID Syndrome

TN
RB
Overseen ByRobert B Innis, M.D.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

You may need to stop taking certain medications like NSAIDs, aspirin, corticosteroids, or immunosuppressants before the PET scan. NSAIDs should not be taken for two weeks prior, and aspirin, corticosteroids, or immunosuppressants should not be taken for a month before the scan.

How does PET imaging differ from other treatments for post-COVID syndrome?

PET imaging is unique because it uses special tracers to visualize metabolic activity in the body, which can help identify inflammation or other changes in tissues that might not be visible with other imaging techniques. This approach is different from standard treatments that typically focus on managing symptoms rather than diagnosing underlying changes.12345

What is the purpose of this trial?

Background:SARS-CoV-2 is the virus that causes COVID-19. Some people who recover from COVID-19 have long-term symptoms that affect the brain. These include headaches; loss of taste and smell; sleep problems; thinking problems; depression; and anxiety. Researchers want to know if a tracer (a substance that is injected into a person s body before an imaging scan) can help identify inflammation in people with these brain disorders.Objective:To see if a radioactive tracer (\[11C\]PS13) can highlight brain inflammation in those who had COVID-19 but still have symptoms that affect the brain.Eligibility:Adults aged 18 to 70 years with post COVID-19 brain disorders who are enrolled in protocol 000089 or 000711. Healthy volunteers are also needed.Design:Participants will have up to 5 clinic visits.Participants will be screened. They will have blood tests and a test of their heart function.They will have imaging scans:Magnetic resonance imaging (MRI): They will lie on a table that slides into a metal tube. Pictures will be taken of the brain.Positron emission tomography (PET): A needle attached to a thin tube will be inserted into a vein in the arm. The tracer will be injected through the tube. Another needle attached to a thin tube will be inserted into the wrist or inside of the elbow of the other arm to draw blood. They will lie still on a bed while a machine captures images of their brain. The scan will last about 2 hours.Study involvement is 11 to 14 weeks....

Research Team

RB

Robert B Innis, M.D.

Principal Investigator

National Institute of Mental Health (NIMH)

Eligibility Criteria

Adults aged 18-70 with long-term brain-related symptoms after COVID-19, who've been screened under specific NIH protocols. They must be in good health, understand the study and consent to it, have no metal in their wrists, adhere to lifestyle requirements, not currently infected with SARS-CoV-2, and be at least six weeks out from initial COVID symptoms.

Inclusion Criteria

Healthy volunteers must have had their radial artery pulse checked for the presence of adequate ulnar collateral flow and the absence of any metal or foreign objects in both wrists
Healthy volunteers must agree to adhere to the lifestyle considerations
Healthy volunteers must report having at least one prior SARS-CoV-2 infection
See 8 more

Exclusion Criteria

I am healthy and have taken NSAIDs within the last two weeks.
Participants with Neuro-PASC who have substance use disorder or alcohol use disorder
Participants with Neuro-PASC who are unable to have an MRI scan
See 17 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Imaging

Participants undergo MRI and PET scans to assess brain inflammation

1-2 weeks
2 visits (in-person)

Treatment

Participants may receive IVIg treatment and undergo a second scan to assess COX-1 expression

4-6 weeks
2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging and treatment

4 weeks
1 visit (in-person)

Treatment Details

Interventions

  • 11C-PS13
Trial Overview The trial is testing a radioactive tracer called [11C]PS13 during PET scans to see if it can show inflammation in the brains of people with neurological issues post-COVID. Participants will also undergo MRI scans and other assessments over an 11-to-14-week period.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: one armExperimental Treatment1 Intervention
All subjects will receive the same tests

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Institute of Mental Health (NIMH)

Lead Sponsor

Trials
3,007
Recruited
2,852,000+

References

18 F-Fluorodeoxy Glucose and 11 C-Methionine Accumulation in Demyelinating Lesions. [2022]
Pitfalls in radiation oncology. "Myocardial metastasis" in PET-CT after palliative radiation treatment of the left 5th rib. [2021]
Usefulness of carbon-11-labeled methionine positron-emission tomography for assessing the treatment response of primary central nervous system lymphoma. [2020]
Tumefactive Demyelination versus Primary Central Nervous System Lymphoma on 18F-Fluorodeoxyglucose Positron Emission Tomography Magnetic Resonance Imaging: A Twist in the Tale. [2020]
Amino Acid Uptake, Glucose Metabolism, and Neuroinflammation in John Cunningham Virus Associated Progressive Multifocal Leukoencephalopathy. [2023]
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