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

First listed
Nov 30, 2018
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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