Evidence of neuroinflammation in fibromyalgia syndrome: a [ 18 F]DPA-714 positron emission tomography study.
Christina Mueller, Yu-Hua D Fang, Chloe Jones...
https://pubmed.ncbi.nlm.nih.gov/37326674/Actively Recruiting
Led by University of Alabama at Birmingham · Updated on 2026-06-02
120
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are studying the levels and distribution of activated brain microglia and macrophages in people with chronic pain and fatigue, conditions suspected to involve neuroinflammation. This study uses a special PET radiopharmaceutical called F-18DPA-714 that binds to a protein found in activated immune cells in the brain, allowing a non-invasive measurement of neuroinflammation. The goal is to see if individuals with fibromyalgia, chronic fatigue syndrome, or multiple sclerosis have higher neuroinflammation compared to healthy volunteers. Participants will undergo imaging with F-18DPA-714 PETMRI to measure brain inflammation levels. The study includes four groups healthy controls, fibromyalgia subjects, chronic fatigue syndrome subjects, and multiple sclerosis subjects. This is a phase 1, non-randomized interventional trial sponsored by the University of Alabama at Birmingham. The imaging procedure allows researchers to observe the presence of neuroinflammation in the brain regions of these groups. During the study, participants will have PETMRI scans to assess neuroinflammation using the tracer F-18DPA-714. The main outcome measured is the difference in neuroinflammation between healthy volunteers and those with pain and fatigue conditions over a 3-year period. Researchers will monitor participants for any contraindications to MRI and ensure safety measures are followed. The study includes adults aged 18 to 65 and involves no blinding or placebo control.
CONDITIONS
Assessment of Neuroinflammation in Central Inflammatory Disorders Using [F-18]DPA-714.
J
Jared Younger, PhD
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University of Alabama at Birmingham
Lead Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Investigational PET/MRI Scan | Current Clinical Diagnostic Pathways |
|---|---|---|
| What is it? | A molecular imaging procedure using [F-18]DPA-714 PET radiotracer combined with MRI to detect neuroinflammation in the brain. Participants undergo the PET/MRI scan after clinical diagnosis or as healthy volunteers. | Diagnosis and monitoring based on clinical assessment, disease-specific diagnostic criteria, conventional MRI (for MS), and laboratory tests. Advanced molecular PET imaging is not used in routine care for these disorders. |
| Role in the trial | Evaluated as an investigational tool to visualize and quantify neuroinflammation in participants with central inflammatory disorders and healthy controls. | Served as the clinical comparator; participants were identified and categorized based on existing clinical and diagnostic criteria prior to PET/MRI imaging. |
| Primary use | Noninvasive molecular imaging to directly assess neuroinflammation, aiming to distinguish patient and healthy control groups based on brain inflammation patterns. | To diagnose and monitor central inflammatory disorders using symptom-based clinical definitions, conventional MRI (especially for MS), and general laboratory testing rather than molecular imaging of inflammation. |
| How is it given or performed? | Participants receive intravenous [F-18]DPA-714 injection, then undergo PET/MRI brain imaging in a single session. | Diagnosis made through patient history, symptom questionnaires, neurological examination, standard MRI for MS, and sometimes laboratory work-up; no molecular PET scan is performed in routine assessment. |
| Evidence status | Ongoing clinical research in this trial population; published pilot studies suggest DPA-714 PET can detect neuroinflammation in fibromyalgia and potentially other central inflammatory disorders. | Widely used for diagnosis; however, conventional approaches do not offer direct molecular imaging of neuroinflammation and may not distinguish subtle brain inflammation. |
| Important limitations | DPA-714 PET/MRI is only available in a research setting, requires specialized radiotracer and imaging equipment, and involves radiation exposure. Clinical significance of imaging findings for individual diagnosis and management is not yet established. | Current clinical pathways may miss subtle neuroinflammatory changes and cannot directly measure molecular neuroinflammation; diagnosis in some conditions relies on exclusion and clinical judgment rather than objective biomarkers. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day procedure
Participants undergo [F-18]DPA-714 PET/MRI imaging to assess neuroinflammation.
1 visit (in-person)
Duration - Up to 3 years
Participants are observed for neuroinflammation outcomes over a period of up to 3 years.
Periodic visits depending on study schedule
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
4
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Christina Mueller, Yu-Hua D Fang, Chloe Jones...
https://pubmed.ncbi.nlm.nih.gov/37326674/University of Alabama at Birmingham
Lead Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborating Sponsor