Measuring brain inflammation in chronic pain and fatigue conditions
Assessment of Neuroinflammation in Central Inflammatory Disorders Using [F-18]DPA-714.
PHASE1 · University of Alabama at Birmingham · NCT03759522
This study is testing a new imaging method to see if people with chronic pain and fatigue, like fibromyalgia and multiple sclerosis, have more brain inflammation compared to healthy individuals.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Alabama at Birmingham (other) |
| Locations | 1 site (Birmingham, Alabama) |
| Trial ID | NCT03759522 on ClinicalTrials.gov |
What this trial studies
This study aims to assess neuroinflammation in individuals with chronic pain and fatigue conditions, such as fibromyalgia and multiple sclerosis, using a PET radiopharmaceutical called [F-18]DPA-714. The study will measure the concentration and regional distribution of activated brain microglia/macrophages, which are indicators of neuroinflammation. By comparing these measurements between patients and healthy controls, the study seeks to determine if patients exhibit higher levels of neuroinflammation. This non-invasive imaging approach will provide insights into the underlying mechanisms of these conditions.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 65 with a clinical diagnosis of multiple sclerosis, fibromyalgia, chronic fatigue syndrome, or healthy volunteers.
Not a fit: Patients with contraindications to MRI, pregnancy, or severe medical conditions that prevent participation in imaging may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better understanding and potential new treatments for chronic pain and fatigue disorders.
How similar studies have performed: Other studies using PET imaging to assess neuroinflammation have shown promise, suggesting this approach may yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Birmingham, Alabama
- University of Alabama at Birmingham Medical Center — Birmingham, Alabama, United States (RECRUITING)
Study contacts
- Study coordinator: Jared Younger, PhD
- Email: youngerlab@uab.edu
- Phone: 205-975-5907
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Fibromyalgia, Chronic Fatigue Syndrome, Multiple Sclerosis, Healthy