Assessment of Neuroinflammation in Central Inflammatory Disorders Using [F-18]DPA-714.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: DPA-714 PET/MRI.
- Who it may be relevant to
- Registry conditions: Fibromyalgia, Chronic Fatigue Syndrome, Multiple Sclerosis, Healthy. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug DPA-714 PET/MRI
DPA-714 PET/MRI
Primary outcome measures
- 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. [Time frame: 3 years]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- University of Alabama at Birmingham Medical Center — Birmingham
Publications
- 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/j.pain.0000000000002927. Epub 2023 Jun 15. PMID 37326674
Identifiers
NCT: NCT03759522 · IRB-300002209 R18-118 · 5R01NS109529-05