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

ConditionsFibromyalgia Chronic Fatigue Syndrome Multiple Sclerosis Healthy

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18-65

SponsorUniversity of Alabama at Birmingham

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Contraindication to MRI

Pregnancy

Lactation

Individuals who are unable to participate in the imaging portion due to severity of their medical condition

Trial design

Design model

Single group

Treatments tested in this trial

DPA-714 PET/MRI
Drug
DPA-714 PET/MRI

Treatment groups

120 Participants

are divided into 4 treatment groups

Group A: Healthy ControlsExperimental treatment 1 intervention

Group B: Fibromyalgia SubjectsExperimental treatment 1 intervention

Group C: Chronic Fatigue Syndrome SubjetsExperimental treatment 1 intervention

Group D: Multiple Sclerosis SubjectsExperimental treatment 1 intervention

Trial outcomes

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.

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.

Time frame

3 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Alabama at Birmingham

Lead sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Source ClinicalTrials.gov

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