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NCT03759522RecruitingPhase 1

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

Source: ClinicalTrials.gov · Last updated 2 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
120 (estimated)
First submitted
6 Nov 2018
Start date
3 Feb 2019
Primary completion date
30 Apr 2028
Lead sponsor
University of Alabama at Birmingham
NCT number
NCT03759522

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 120
  • From 3 Feb 2019 to the primary completion date, 30 Apr 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Currently enrolled in a clinical trial utilizing experimental therapies

Other illness

  • Individuals who are unable to participate in the imaging portion due to severity of their medical condition
  • Chronic infectious disease (e.g. HIV, HCV)
  • Viral or bacterial illness requiring medical attention and/or antibiotics within 1 month of study participation
  • Diagnosis of cancer, including leukemia
  • Blood or blood clotting disorder
  • Except for individuals with MS, a diagnosis of autoimmune disease is exclusionary

Lab values

  • Positive urine β-hCG test day of procedure or a serum -hCG test within 48 hours prior to the administration of \[18F\]DPA-714

Other

  • Contraindication to MRI
  • Pregnancy
  • Lactation

Who the study is looking for

  • 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

Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Alabama at Birmingham Medical Center
Coordinator of this site? Confirm its status
BirminghamUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.