Assessment of Neuroinflammation in Central Inflammatory Disorders Using [F-18]DPA-714.

Study Overview
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Brief Summary
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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.

Official Title
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Assessment of Neuroinflammation in Central Inflammatory Disorders Using [F-18]DPA-714.

Conditions
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Fibromyalgia, Chronic Fatigue Syndrome, Multiple Sclerosis, Healthy

Intervention / Treatment
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* Drug: DPA-714 PET/MRI


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy Controls<br> | Drug: DPA-714 PET/MRI<br>* DPA-714 PET/MRI<br>|
| Experimental: Fibromyalgia Subjects<br> | Drug: DPA-714 PET/MRI<br>* DPA-714 PET/MRI<br>|
| Experimental: Chronic Fatigue Syndrome Subjets<br> | Drug: DPA-714 PET/MRI<br>* DPA-714 PET/MRI<br>|
| Experimental: Multiple Sclerosis Subjects<br> | Drug: DPA-714 PET/MRI<br>* DPA-714 PET/MRI<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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/or fatigue. | 3 years |