Recruiting
Phase 1

Neuroinflammation Assessment

Sponsor:

University of Alabama at Birmingham

Code:

NCT03759522

Conditions

Fibromyalgia

Chronic Fatigue Syndrome

Multiple Sclerosis

Healthy

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

DPA-714 PET/MRI

Study Details

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.

Conditions

Fibromyalgia

Chronic Fatigue Syndrome

Multiple Sclerosis

Healthy

Study ID

NCT03759522

Start date

Feb 3, 2019

Status verified date

Feb, 2026

Completion date

Apr, 2028

Anticipated

Primary completion date

Apr, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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

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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Healthy Controls

experimental: Fibromyalgia Subjects

experimental: Chronic Fatigue Syndrome Subjets

experimental: Multiple Sclerosis Subjects

Interventions

DPA-714 PET/MRI

DPA-714 PET/MRI

Primary outcome measure

  • 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. [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

Jared Younger, PhD

205-975-5907youngerlab@uab.edu

Locations

University of Alabama at Birmingham Medical Center

Recruiting

Birmingham, Alabama, United States, 35294

Contacts

Jonathan McConathy, MD

205-996-7115jmcconathy@uabmc.edu

Principal Investigator:

Jonathan McConathy, MD, PhD

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Jun 2, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2026-06-02.