Actively Recruiting

Phase 1
Age: 18Years - 65Years
All Genders
Healthy Volunteers
ID03759522

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

Led by University of Alabama at Birmingham · Updated on 2026-06-02

120

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of Alabama at Birmingham

Lead Sponsor

N

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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-18]DPA-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-18]DPA-714 PET/MRI 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 PET/MRI scans to assess neuroinflammation using the tracer [F-18]DPA-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

Brief Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 65 years
  • Healthy volunteer or clinical diagnosis of multiple sclerosis
  • Meets 2016 American College of Rheumatology criteria for fibromyalgia
  • Meets 1994 Fukuda criteria for chronic fatigue syndrome
Not Eligible

You will not qualify if you...

  • Contraindication to MRI
  • Pregnancy
  • Lactation
  • Unable to participate in imaging due to severe medical condition
  • Chronic infectious diseases such as HIV or HCV
  • Viral or bacterial illness requiring medical attention or antibiotics within 1 month
  • Diagnosis of cancer, including leukemia
  • Blood or blood clotting disorders
  • Autoimmune disease diagnosis excluding multiple sclerosis patients
  • Positive urine or serum beta-hCG test near time of procedure
  • Currently enrolled in clinical trials with experimental therapies

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Single day procedure

Participants undergo [F-18]DPA-714 PET/MRI imaging to assess neuroinflammation.

1 visit (in-person)

Long-term Monitoring

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

Trial Site Locations

Total: 1 location

1

University of Alabama at Birmingham Medical Center

Birmingham, Alabama, United States, 35294

Actively Recruiting

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Research Team

J

Jared Younger, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

4

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Published Research Related To This Trial