NCT03759522|RecruitingPhase 1FDA Drug
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Sponsor study identifier
Secondary identifiers
interventional
120
1 country
1
Study Start
February 3, 2019
Actual (reported)Primary Completion
April 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
April 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 6, 2018
Actual (reported)November 30, 2018
Actual (reported)February 3, 2019
Actual (reported)April 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
April 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
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.
3 years
DPA-714 PET/MRI
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University of Alabama at Birmingham Medical Center
Birmingham, Alabama, 35294, United States
Mueller C, Fang YD, Jones C, McConathy JE, Raman F, Lapi SE, Younger JW. Evidence of neuroinflammation in fibromyalgia syndrome: a [ 18 F]DPA-714 positron emission tomography study. Pain. 2023 Oct 1;164(10):2285-2295. doi: 10.1097/j.pain.0000000000002927. Epub 2023 Jun 15.
First Submitted
November 6, 2018
First Posted
November 30, 2018
Study Start
February 3, 2019
Actual (reported)Primary Completion
April 2028
EstimatedMechanisms of Ozone-Induced Alterations in Efferocytosis and Phagocytosis
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Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
April 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
June 2, 2026
Record last verified: 2026-02
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Source: ClinicalTrials.gov.
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