Status:
RECRUITING
Assessment of Neuroinflammation in Central Inflammatory Disorders Using [F-18]DPA-714.
Lead Sponsor:
University of Alabama at Birmingham
Conditions:
Fibromyalgia
Chronic Fatigue Syndrome
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The primary objective of this study is to measure the concentration and the regional brain distribution of activated brain microglia/macrophages using the PET radiopharmaceutical \[F-18\]DPA-714 in in...
Eligibility Criteria
Inclusion
- 18 to 65 years of age
- 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
Exclusion
- Contraindication to MRI
- Pregnancy
- Lactation
- 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 MS, a diagnosis of autoimmune disease is exclusionary
- Positive urine β-hCG test day of procedure or a serum -hCG test within 48 hours prior to the administration of \[18F\]DPA-714
- Currently enrolled in a clinical trial utilizing experimental therapies
Key Trial Info
Start Date :
February 3 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 10 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03759522
Start Date
February 3 2019
End Date
April 10 2026
Last Update
December 18 2024
Active Locations (1)
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1
University of Alabama at Birmingham Medical Center
Birmingham, Alabama, United States, 35294