RecruitingRecruiting
Assessment of Neuroinflammation in Central Inflammatory Disorders Using [F-18]DPA-714.
NCT03759522 · University of Alabama at Birmingham
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
About this study
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 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/macrophages 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/MRI.
Eligibility criteria
Inclusion Criteria:
1. 18 to 65 years of age
2. 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 Criteria:
1. Contraindication to MRI
2. Pregnancy
3. Lactation
4. Individuals who are unable to participate in the imaging portion due to severity of their medical condition
5. Chronic infectious disease (e.g. HIV, HCV)
6. Viral or bacterial illness requiring medical attention and/or antibiotics within 1 month of study participation
7. Diagnosis of cancer, including leukemia
8. Blood or blood clotting disorder
9. Except for individuals with MS, a diagnosis of autoimmune disease is exclusionary
10. Positive urine β-hCG test day of procedure or a serum -hCG test within 48 hours prior to the administration of \[18F\]DPA-714
11. Currently enrolled in a clinical trial utilizing experimental therapies
Study design
Enrollment target: 120 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2019-02-03
Estimated completion: 2028-04
Last updated: 2026-06-02
Interventions
Drug: DPA-714 PET/MRI
Primary outcomes
- • 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/MRI. (3 years)
Sponsor
University of Alabama at Birmingham · other
With: National Institute of Neurological Disorders and Stroke (NINDS)
Contacts & investigators
ContactJared Younger, PhD · contact · youngerlab@uab.edu · 205-975-5907
All locations (1)
University of Alabama at Birmingham Medical CenterRecruiting
Birmingham, Alabama, United States