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NCT Number: NCT03759522

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

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.

Recruiting

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Key information

Conditions

Fibromyalgia Autoimmune Diseases Autoimmune Diseases of the Nervous System Chronic Disease Chronic Fatigue Syndrome Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Disease Attributes Encephalomyelitis Fatigue Syndrome, Chronic Healthy Immune System Diseases Multiple Sclerosis Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuroinflammatory Diseases Neuromuscular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Rheumatic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Alabama at Birmingham Medical Center

Birmingham, Alabama, 35294, United States

Location status: Recruiting

Location contact

Bag Asim, MD

SUB_INVESTIGATOR

Bhambhvani Pradeep, MD

SUB_INVESTIGATOR

Choudhary Gagandeep, MD

SUB_INVESTIGATOR

Geldmacher David, MD

SUB_INVESTIGATOR

Jeffers Charlotte Denise, RPh

SUB_INVESTIGATOR

Jonathan McConathy, MD

CONTACT

[email protected]

205-996-7115

Jonathan McConathy, MD, PhD

PRINCIPAL_INVESTIGATOR

Lapi Suzanne, PhD

SUB_INVESTIGATOR

Natelson Marissa, MD

SUB_INVESTIGATOR

Roberson Erik, MD, PhD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Contraindication to MRI
  • Pregnancy
  • Lactation
  • 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
  • Positive urine β-hCG test day of procedure or a serum -hCG test within 48 hours prior to the administration of [18F]DPA-714
  • Currently enrolled in a clinical trial utilizing experimental therapies

Treatment and study plan

DPA-714 PET/MRI

Drug

DPA-714 PET/MRI

Primary outcomes

  1. 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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jared Younger, PhD

CONTACT

[email protected]

205-975-5907

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Important dates

Study start
2019
Primary completion
2028
Study completion
2028
First posted
Nov 30, 2018
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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