Multiple Sclerosis Clinical Trial

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

Summary

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.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Multiple Sclerosis

Phase:

Phase 1

Estimated Enrollment:

120

Study ID:

NCT03759522

Recruitment Status:

Recruiting

Sponsor:

University of Alabama at Birmingham

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There is 1 Location for this study

See Locations Near You

University of Alabama at Birmingham Medical Center
Birmingham Alabama, 35294, United States More Info
Jonathan McConathy, MD
Contact
205-996-7115
[email protected]
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

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 1

Estimated Enrollment:

120

Study ID:

NCT03759522

Recruitment Status:

Recruiting

Sponsor:


University of Alabama at Birmingham

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.