Actively Recruiting

Early Phase 1
Age: 18Years - 65Years
All Genders
Healthy Volunteers
ID05656105

PET Imaging of Neuroinflammation in Patients With Neurological Dysfunction After SARS-CoV-2 Infection

Led by University of Alabama at Birmingham · Updated on 2026-06-02

60

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating neuroinflammation in individuals with neurological symptoms following SARS-CoV-2 infection, known as post-acute sequelae of SARS-CoV-2 (PASC). This early phase 1 clinical imaging study uses a small molecule ligand called Fluorodeoxyglucose(18F)-labeled DPA-714 to visualize and measure brain inflammation by targeting the translocator protein (TSPO). The brain uptake of this ligand in PASC patients will be compared with that of healthy volunteers to better understand neurological effects of the condition. Participants will undergo PET/MRI scans using the DPA-714 ligand to assess regional brain TSPO levels. The study includes two groups: individuals with neurological PASC symptoms and healthy volunteers without neurological symptoms. Participants are grouped based on their genetic affinity for TSPO ligands and will receive the imaging procedure once. This non-randomized study does not involve blinding and is designed to collect imaging data within a short follow-up period. During the study, participants will receive an injection of the DPA-714 tracer followed by PET/MRI imaging. Researchers will measure TSPO levels in the brain to detect neuroinflammation. The primary outcome is the measurement of brain TSPO levels from the scan to clinical follow-up, usually within six weeks. Participants will be screened for eligibility including genetic testing for TSPO affinity and undergo safety checks such as pregnancy tests and blood work. The total study participation involves the imaging session and follow-up assessments to monitor results and safety.

CONDITIONS

Brief Title

Positron Emission Tomography (PET) Imaging of Neuroinflammation in Patients With Neurological Dysfunction After Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV 2) Infection

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 65 years
  • Healthy volunteer or clinical diagnosis of post-acute sequelae of SARS-CoV-2 (PASC)
  • High or mixed affinity binder for TSPO ligands based on genotyping for SNP rs6971
  • PASC participants must have confirmed prior SARS-CoV-2 infection with neurological symptoms present for at least four weeks
  • Healthy controls must have no neurological symptoms
Not Eligible

You will not qualify if you...

  • Contraindication to MRI
  • Pregnancy or lactation
  • Unable to participate in imaging due to severe medical condition
  • Chronic infectious diseases such as HIV or hepatitis C
  • Recent viral or bacterial illness requiring medical care within one month
  • Diagnosis of cancer including leukemia
  • Blood or clotting disorders
  • Autoimmune diseases except multiple sclerosis
  • Positive pregnancy test at or before procedure
  • Current participation in clinical trials using experimental therapies
  • Low affinity binder for TSPO ligands based on SNP rs6971 genotyping
  • History of moderate or severe traumatic brain injury or whiplash
  • History of inflammatory bowel disease (IBD); irritable bowel syndrome (IBS) without inflammation allowed
  • Abnormal blood test results indicating infection, anemia, organ damage, or inflammation
  • Use of illicit substances within six months
  • Diagnosis of Type I or II diabetes
  • Healthy controls must not regularly use anti-inflammatory, analgesic (except aspirin), or sleep medications

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 6 weeks

Participants undergo PET/MRI imaging to measure regional brain TSPO levels related to neuroinflammation.

1 imaging visit and 1 clinical follow-up visit

Trial Site Locations

Total: 1 location

1

UAB

Birmingham, Alabama, United States, 35249

Actively Recruiting

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Research Team

A

April Riddle

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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