ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03759522
Recruitment Status : Not yet recruiting
First Posted : November 30, 2018
Last Update Posted : November 30, 2018
Sponsor:
Information provided by (Responsible Party):
Jonathan E McConathy, University of Alabama at Birmingham

Brief 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 [18F]DPA-714 in individuals with chronic pain and fatigue suspected to be associated with neuroinflammation. The PET tracer [18F]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 [18F]DPA-714-PET/MRI.

Condition or disease Intervention/treatment Phase
Fibromyalgia Chronic Fatigue Syndrome Multiple Sclerosis Healthy Drug: DPA-714 PET/MRI Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Assessment of Neuroinflammation in Central Inflammatory Disorders Using [18F]DPA-714.
Estimated Study Start Date : February 1, 2019
Estimated Primary Completion Date : November 1, 2021
Estimated Study Completion Date : November 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Neuroinflammation will be measured in healthy volunteers and compared to neuroinflammation in individuals with pain and fatigue, as measured with [18F]DPA-714-PET/MRI. [ Time Frame: 3 years ]
    Quantitative PET measures of TSPO binding in brain regions including cerebral cortex, thalami, and brainstem will be compared between healthy volunteers and symptomatic study participants with pain and/or fatigue. We hypothesize that symptomatic participants will have greater TSPO binding in one or more brain regions than healthy volunteers due to the presence of neuroinflammation.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03759522


Contacts
Contact: Jonathan McConathy, MD, PhD 205-996-7115 jmconathy@uabmc.edu
Contact: April Riddle, BSRT 205-934-6504 ariddle@uabmc.edu

Sponsors and Collaborators
University of Alabama at Birmingham

Responsible Party: Jonathan E McConathy, M.D. P.h.D., Director for the Division Molecular Imaging and Therapeutics, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03759522     History of Changes
Other Study ID Numbers: R18-118
First Posted: November 30, 2018    Key Record Dates
Last Update Posted: November 30, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Multiple Sclerosis
Fatigue
Fibromyalgia
Fatigue Syndrome, Chronic
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Virus Diseases
Encephalomyelitis
Central Nervous System Diseases