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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT03759522
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • DPA-714 PET/MRI — DRUG
    DPA-714 PET/MRI

Study Details

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.

Key Dates

Start date
Feb 3, 2019
Status verified
Feb 2026
Primary completion
Apr 30, 2028
Completion
Apr 30, 2028

Study Design

Enrollment
120 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Healthy Controls
  • Experimental: Fibromyalgia Subjects
  • Experimental: Chronic Fatigue Syndrome Subjets
  • Experimental: Multiple Sclerosis Subjects

Primary Outcome Measure

Neuroinflammation will be measured in healthy volunteers and compared to neuroinflammation in individuals with pain and fatigue, as measured with [F-18]DPA-714-PET/MRI. [ Time Frame: 3 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Alabama at Birmingham Medical CenterBirminghamAlabama35294
Jonathan McConathy, MD
[email protected]
205-996-7115
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)

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University of Alabama at Birmingham Medical Center· Birmingham, AL

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