PET Imaging of Neuroinflammation in Patients With Neurological Dysfunction After SARS-CoV-2 Infection
Overview
- Phase
- Early Phase 1
- Intervention
- DPA-714 PET/MRI
- Conditions
- SARS CoV-2 Post-Acute Sequelae
- Sponsor
- University of Alabama at Birmingham
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Measurement of regional brain TSPO levels using PET in participants with neurological PASC and healthy volunteers
- Status
- Recruiting
- Last Updated
- 4 months ago
Overview
Brief Summary
This clinical imaging study will use the small molecule translocator protein (TSPO) ligand, Fluorodeoxyglucose(18F)-labeled DPA-714, to visualize and quantify neuroinflammation in individuals with post-acute sequelae of SARS-CoV-2 (PASC) . The brain uptake of DPA-714 will be contrasted with healthy subjects.
Investigators
Jonathan E McConathy
M.D. P.h.D., Director for the Division Molecular Imaging and Therapeutics
University of Alabama at Birmingham
Eligibility Criteria
Inclusion Criteria
- •18 to 65 years of age
- •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 single nucleotide polymorphism (SNP) rs
- •PASC participants must have been previously infected with SARS-CoV-
- •Their neurological symptoms must have been present for at least four weeks prior to the enrollment.
- •Healthy control participants must have no neurological symptoms
Exclusion Criteria
- •Contraindication to MRI
- •Individuals who are unable to participate in the imaging portion due to severity of their medical condition
- •Chronic infectious disease (e.g. HIV, HCV)
- •Viral or bacterial illness requiring medical attention and/or antibiotics within 1 month of study participation
- •Diagnosis of cancer, including leukemia
- •Blood or blood clotting disorder
- •Except for individuals with Multiple Sclerosis (MS), a diagnosis of autoimmune disease is exclusionary
- •Positive urine β-hCG test day of procedure or a serum human chorionic gonadotropin (hCG) test within 48 hours prior to the administration of \[18F\]DPA-714.
- •11Currently enrolled in a clinical trial utilizing experimental therapies.
- •Currently taking experimental therapies
Arms & Interventions
Healty Volunteers
Intervention: DPA-714 PET/MRI
PASC
Patients meeting the case definition criteria for PASC
Intervention: DPA-714 PET/MRI
Outcomes
Primary Outcomes
Measurement of regional brain TSPO levels using PET in participants with neurological PASC and healthy volunteers
Time Frame: Injection/scan date to clinical follow-up. (Usually within 6 weeks)
PET measures of TSPO binding in brain regions including cerebral cortex, thalami, and brainstem will be quantified in symptomatic study participants and healthy volunteers will be collected and compared between groups