[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT03759522":3,"trial-entities:NCT03759522":103,"trial-summary:NCT03759522":106},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":14,"conditions":16,"keywords":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":38,"secondary_outcomes":43,"sex":44,"minimum_age":45,"maximum_age":46,"healthy_volunteers":47,"eligibility_criteria":48,"std_ages":52,"locations":55,"central_contacts":91,"overall_officials":96,"references":97,"see_also_links":102},"NCT03759522","IRB-300002209 R18-118","Assessment of Neuroinflammation in Central Inflammatory Disorders Using [F-18]DPA-714.","RECRUITING","2028-04","2026-02","2026-06-02","2019-02-03","University of Alabama at Birmingham","OTHER",null,"The primary objective of this study is to measure the concentration and the regional brain distribution of activated brain microglia\u002Fmacrophages using the PET radiopharmaceutical \\[F-18\\]DPA-714 in individuals with chronic pain and fatigue suspected to be associated with neuroinflammation. The PET tracer \\[F-18\\]DPA-714 binds to the 18 kDa translocator protein (TSPO, also known as the peripheral benzodiazepine receptor) in the mitochondria of activated microglia\u002Fmacrophages and provides a non-invasive measure of neuroinflammation. The primary objective of this study is to determine if pain and fatigue patients have higher levels of neuroinflammation than HC individuals as measured with \\[F-18\\]DPA-714-PET\u002FMRI.",[17,18,19,20],"Fibromyalgia","Chronic Fatigue Syndrome","Multiple Sclerosis","Healthy",[],"INTERVENTIONAL","DIAGNOSTIC",[25],"PHASE1",{"count":27,"type":28},120,"ESTIMATED",[30],{"type":31,"name":32,"description":32,"armGroupLabels":33},"DRUG","DPA-714 PET\u002FMRI",[34,35,36,37],"Chronic Fatigue Syndrome Subjets","Fibromyalgia Subjects","Healthy Controls","Multiple Sclerosis Subjects",[39],{"measure":40,"description":41,"timeFrame":42},"Neuroinflammation will be measured in healthy volunteers and compared to neuroinflammation in individuals with pain and fatigue, as measured with [F-18]DPA-714-PET\u002FMRI.","Quantitative PET measures of TSPO binding in brain regions including cerebral cortex, thalami, and brainstem will be compared between healthy volunteers and symptomatic study participants with pain and\u002For fatigue.","3 years",[],"ALL","18 Years","65 Years",true,{"inclusion":49,"exclusion":50,"raw_text":51},[],[],"Inclusion Criteria:\n\n1. 18 to 65 years of age\n2. Healthy volunteer OR Clinical diagnosis of Multiple Sclerosis (MS) OR Meets 2016 American College of Rheumatology (ACR) case definition criteria for fibromyalgia OR Meets 1994 Fukuda case definition criteria for Chronic Fatigue Syndrome\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 MS, a diagnosis of autoimmune disease is exclusionary\n10. Positive urine β-hCG test day of procedure or a serum -hCG test within 48 hours prior to the administration of \\[18F\\]DPA-714\n11. Currently enrolled in a clinical trial utilizing experimental therapies",[53,54],"ADULT","OLDER_ADULT",[56],{"facility":57,"status":7,"city":58,"state":59,"zip":60,"country":61,"contacts":62,"geoPoint":88},"University of Alabama at Birmingham Medical Center","Birmingham","Alabama","35294","United States",[63,68,71,74,76,78,80,82,84,86],{"name":64,"role":65,"phone":66,"email":67},"Jonathan McConathy, MD","CONTACT","205-996-7115","jmcconathy@uabmc.edu",{"name":69,"role":70},"Jonathan McConathy, MD, PhD","PRINCIPAL_INVESTIGATOR",{"name":72,"role":73},"Bag Asim, MD","SUB_INVESTIGATOR",{"name":75,"role":73},"Bhambhvani Pradeep, MD",{"name":77,"role":73},"Choudhary Gagandeep, MD",{"name":79,"role":73},"Geldmacher David, MD",{"name":81,"role":73},"Lapi Suzanne, PhD",{"name":83,"role":73},"Jeffers Charlotte Denise, RPh",{"name":85,"role":73},"Natelson Marissa, MD",{"name":87,"role":73},"Roberson Erik, MD, PhD",{"lat":89,"lon":90},33.52066,-86.80249,[92],{"name":93,"role":65,"phone":94,"email":95},"Jared Younger, PhD","205-975-5907","youngerlab@uab.edu",[],[98],{"pmid":99,"type":100,"citation":101},"37326674","DERIVED","Mueller C, Fang YD, Jones C, McConathy JE, Raman F, Lapi SE, Younger JW. Evidence of neuroinflammation in fibromyalgia syndrome: a [ 18 F]DPA-714 positron emission tomography study. Pain. 2023 Oct 1;164(10):2285-2295. doi: 10.1097\u002Fj.pain.0000000000002927. Epub 2023 Jun 15.",[],{"nct_id":4,"conditions":104,"biomarkers":105},[18,17,20,19],[],{"nct_id":4,"found":47,"summary":107,"prompt_version":117},{"design":108,"status":109,"heading":110,"summary":111,"follow_up":112,"word_count":113,"commitments":114,"compensation":115,"drugs_mentioned":116},"This interventional study plans to enroll 120 participants. It will compare neuroinflammation levels in healthy volunteers to those with specific chronic pain and fatigue conditions.","completed","Understanding Neuroinflammation in Chronic Pain and Fatigue","This study aims to understand if people with chronic pain and fatigue, such as those with Fibromyalgia, Chronic Fatigue Syndrome, or Multiple Sclerosis, have higher levels of brain inflammation (neuroinflammation) compared to healthy individuals. Researchers will use a special imaging technique called DPA-714 PET\u002FMRI. This involves a small amount of a radioactive tracer called [F-18]DPA-714, which helps to visualize activated brain cells (microglia\u002Fmacrophages) that are involved in inflammation. The study is looking for 120 participants, including healthy volunteers and individuals aged 18 to 65 with these conditions. The main goal is to see if there's a difference in neuroinflammation levels between these groups, measured over three years. The current status of this study is unclear.","Neuroinflammation will be measured at 3 years.",115,"Not specified in the trial record.","Not stated in the trial record.",[32],"v2"]