Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Single Group Assignment
Primary Purpose
Diagnostic
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Healthy Controls
  • Drug: DPA-714 PET/MRI
    DPA-714 PET/MRI
Experimental
Fibromyalgia Subjects
  • Drug: DPA-714 PET/MRI
    DPA-714 PET/MRI
Experimental
Chronic Fatigue Syndrome Subjets
  • Drug: DPA-714 PET/MRI
    DPA-714 PET/MRI
Experimental
Multiple Sclerosis Subjects
  • Drug: DPA-714 PET/MRI
    DPA-714 PET/MRI

Recruiting Locations

University of Alabama at Birmingham Medical Center
Birmingham, Alabama 35294
Contact:
Jonathan McConathy, MD
205-996-7115
jmcconathy@uabmc.edu

More Details

Status
Recruiting
Sponsor
University of Alabama at Birmingham

Study Contact

Jonathan McConathy, MD, PhD
205-996-7115
jmcconathy@uabmc.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.