Assessment of Neuroinflammation in Central Inflammatory Disorders Using [F-18]DPA-714.
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 65 Years
- Sex
- All sexes
- Healthy volunteers
- Accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: MRI scans
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study uses PET/MRI brain scans and a tracer called [F-18]DPA-714 to measure brain inflammation. It compares people with long-term pain and fatigue to healthy volunteers to see if they have more brain inflammation.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You are 18 to 65 years old.
- You are a healthy volunteer, have diagnosed multiple sclerosis (MS), or meet the study's diagnosis rules for fibromyalgia or chronic fatigue syndrome.
Who can't join
- You cannot safely have an MRI, or your health condition is too severe for you to take part in the scans.
- You are pregnant, breastfeeding, or have a positive pregnancy test on the scan day or within 48 hours before receiving the tracer.
- You have a long-term infection, such as HIV or hepatitis C.
- You had a viral or bacterial illness needing medical care or antibiotics within 1 month before taking part.
- You have been diagnosed with cancer, including leukemia (a blood cancer).
- You have a blood disorder or a problem with blood clotting.
- You have an autoimmune disease, where the body's defenses attack its own tissues, other than MS.
- You are currently in a clinical trial that uses experimental treatments.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility 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
Study sites (1)
AL
- University of Alabama at Birmingham Medical Center · Birmingham, AL 35294Jonathan McConathy, MD · Study contact · 205-996-7115 · jmcconathy@uabmc.eduJonathan McConathy, MD, PhD · Principal investigatorBag Asim, MD · Sub-investigatorBhambhvani Pradeep, MD · Sub-investigatorMore trials in Birmingham