[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05656105":3,"trial-entities:NCT05656105":77,"trial-summary:NCT05656105":82},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":35,"secondary_outcomes":40,"sex":41,"minimum_age":42,"maximum_age":43,"healthy_volunteers":15,"eligibility_criteria":44,"std_ages":48,"locations":51,"central_contacts":70,"overall_officials":73,"references":75,"see_also_links":76},"NCT05656105","IRB-300010479 R22-209","Positron Emission Tomography (PET) Imaging of Neuroinflammation in Patients With Neurological Dysfunction After Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV 2) Infection","PET Imaging of Neuroinflammation in Patients With Neurological Dysfunction After SARS-CoV-2 Infection","RECRUITING","2028-06-01","2026-08","2026-08-12","2023-11-10","University of Alabama at Birmingham","OTHER",true,"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.",null,[19],"SARS CoV-2 Post-Acute Sequelae",[],"INTERVENTIONAL","DIAGNOSTIC",[24],"EARLY_PHASE1",{"count":26,"type":27},60,"ESTIMATED",[29],{"type":30,"name":31,"description":31,"armGroupLabels":32},"DRUG","DPA-714 PET\u002FMRI",[33,34],"Healty Volunteers","PASC",[36],{"measure":37,"description":38,"timeFrame":39},"Measurement of regional brain TSPO levels using PET in participants with neurological PASC and healthy volunteers","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","Injection\u002Fscan date to clinical follow-up. (Usually within 6 weeks)",[],"ALL","18 Years","65 Years",{"inclusion":45,"exclusion":46,"raw_text":47},[],[],"Inclusion Criteria:\n\n1. 18 to 65 years of age\n2. Healthy volunteer OR Clinical diagnosis of post-acute sequelae of SARS-CoV-2 (PASC)\n3. High or mixed affinity binder for TSPO ligands based on genotyping for single nucleotide polymorphism (SNP) rs6971.\n4. PASC participants must have been previously infected with SARS-CoV-2. Their neurological symptoms must have been present for at least four weeks prior to the enrollment.\n5. Healthy control participants must have no neurological symptoms\n\nExclusion Criteria:\n\n1. Contraindication to MRI\n2. Pregnancy\n3. Lactation\n4. Individuals who are unable to participate in the imaging portion due to severity of their medical condition\n5. Chronic infectious disease (e.g. HIV, HCV)\n6. Viral or bacterial illness requiring medical attention and\u002For antibiotics within 1 month of study participation\n7. Diagnosis of cancer, including leukemia\n8. Blood or blood clotting disorder\n9. Except for individuals with Multiple Sclerosis (MS), a diagnosis of autoimmune disease is exclusionary\n10. 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-714.11.\n\n11Currently enrolled in a clinical trial utilizing experimental therapies. 12. Currently taking experimental therapies 13. Low affinity binder for TSPO ligands based on genotyping for SNP rs6971.\n\nThe following exclusionary criteria apply only to PASC patients and healthy controls:\n\n14\\. Self-reported history of moderate or severe traumatic brain injury 15. Self-reported history of whiplash injury 16. Self-reported history of Inflammatory bowel disease (IBD). (Individuals with Irritable Bowel Syndrome (IBS) and no signs of inflammation will be allowed to participate.) 17. The following blood test results (at screening) will be exclusionary: 18. Rheumatoid Factor (RF) =\\> 14 IntUnits\u002FmL, 19. Anti-nuclear antibody (ANA) \\> 1:80, 20. Erythrocyte sedimentation rate (ESR) \\> 60mm\u002Fhour, 21.High sensitivity C-reactive protein (hsCRP) \\> 10mg\u002FL, 22. Complete blood count (CBC) results indicating acute infection, anemia, or other condition, 23. T3, T4, or thyroid-stimulating hormone (TSH) levels out of normal range, 24. Fasting glucose \\> 100 mg\u002FdL, 25. Blood chemistry results indicating organ damage or other serious medical condition 26. Use of illicit substances within the past 6 months 27. Self-reported diagnosis of Type I or Type II diabetes 28. Healthy controls must not regularly take over-the-counter anti-inflammatory medication, analgesics (except aspirin), or sleep medication",[49,50],"ADULT","OLDER_ADULT",[52],{"facility":53,"status":8,"city":54,"state":55,"zip":56,"country":57,"contacts":58,"geoPoint":67},"UAB","Birmingham","Alabama","35249","United States",[59,64],{"name":60,"role":61,"phone":62,"email":63},"April Riddle","CONTACT","2059961082","RadiologyCRC@uabmc.edu",{"name":65,"role":66},"Jonathan McConathy, MD, PhD","PRINCIPAL_INVESTIGATOR",{"lat":68,"lon":69},33.52066,-86.80249,[71],{"name":60,"role":61,"phone":72,"email":63},"205-9961082",[74],{"name":65,"affiliation":13,"role":66},[],[],{"nct_id":4,"conditions":78,"biomarkers":80},[79],"SARS-CoV-2 Post-Acute Sequelae",[81],"TSPO Gene",{"nct_id":4,"found":15,"summary":83,"prompt_version":93},{"design":84,"status":85,"heading":86,"summary":87,"follow_up":88,"word_count":89,"commitments":90,"compensation":91,"drugs_mentioned":92},"This is an interventional imaging study planning to enroll 60 participants. It compares individuals with post-acute COVID-19 symptoms to healthy volunteers.","completed","Imaging Neuroinflammation After COVID-19","This study is looking at brain inflammation in people who have ongoing health issues after a SARS-CoV-2 (COVID-19) infection. It uses a special imaging technique called DPA-714 PET\u002FMRI to visualize and measure inflammation in the brain. Researchers will compare these images with those from healthy volunteers. To join, you must be between 18 and 65 years old and have either had COVID-19 with ongoing symptoms or be a healthy volunteer. You also need to have a specific genetic marker (SNP rs6971) that affects how your body interacts with the imaging agent. The goal is to see if there's a difference in brain inflammation between these groups. The study is currently unclear on its recruitment status.","Participants will have a clinical follow-up, usually within 6 weeks of their injection\u002Fscan date.",115,"You would undergo a DPA-714 PET\u002FMRI scan. The primary measurement will be taken at the time of injection\u002Fscan and followed up within about 6 weeks.","Not stated in the trial record.",[31],"v2"]