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

Phase 1

Recruiting

• Conditions: Fibromyalgia; Chronic Fatigue Syndrome; Multiple Sclerosis; Healthy
• Interventions: Drug: DPA-714 PET/MRI

• Registration Number: NCT03759522
• Lead Sponsor: University of Alabama at Birmingham

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-11-06
• Study First Submitted QC: 2018-11-28
• Study First Posted: 2018-11-30
• Study Start: 2019-02-03
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-13
• Last Update Posted: 2024-12-18
• Primary Completion: 2026-04-10
• Study Completion: 2026-04-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healthy Controls	DPA-714 PET/MRI	-
Fibromyalgia Subjects	DPA-714 PET/MRI	-
Chronic Fatigue Syndrome Subjets	DPA-714 PET/MRI	-
Multiple Sclerosis Subjects	DPA-714 PET/MRI	-

Primary Outcome Measures

Name	Time	Method
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	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.

Trial Locations

Locations (1)

University of Alabama at Birmingham Medical Center; 🇺🇸 Birmingham, Alabama, United States