What this study is
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.
What's being tested
- DPA-714 PET/MRI
Intervention · DRUG
DPA-714 PET/MRI
Study details
- Sponsor
- University of Alabama at Birmingham
- Conditions
- Fibromyalgia · Chronic Fatigue Syndrome · Multiple Sclerosis · Healthy
- Enrolling
- 120 people
- Starts
- 2019-02-03
- Est. completion
- 2028-04
- Design
- Open-label, non-randomized, single group, Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 65 YearsSex ALLHealthy volunteers AcceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (1)
1 openUniversity of Alabama at Birmingham Medical Center
Birmingham, Alabama, United States
- Jonathan McConathy, MD · Contact205-996-7115jmcconathy@uabmc.edu
- Jonathan McConathy, MD, PhD · Principal investigator
- Bag Asim, MD · Sub-investigator
- Bhambhvani Pradeep, MD · Sub-investigator
- Choudhary Gagandeep, MD · Sub-investigator
- Geldmacher David, MD · Sub-investigator
- Lapi Suzanne, PhD · Sub-investigator
- Jeffers Charlotte Denise, RPh · Sub-investigator
- Natelson Marissa, MD · Sub-investigator
- Roberson Erik, MD, PhD · Sub-investigator
Recruiting
Study team
Sponsor
University of Alabama at Birmingham
Study ID IRB-300002209 R18-118
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.