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Neuroinflammation in Asymptomatic Carotid Artery Disease - Imaging Substudy

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ClinicalTrials.gov Identifier: NCT05238961
Recruitment Status : Not yet recruiting
First Posted : February 14, 2022
Last Update Posted : June 30, 2022
Sponsor:
Information provided by (Responsible Party):
Jonathan E McConathy, University of Alabama at Birmingham

Brief Summary:
This clinical imaging substudy will use the small molecule translocator protein (TSPO) ligand, Fludeoxyglucose(18F)-labeled DPA-714, to compare neuroinflammation in individuals with high or low grade asymptomatic carotid artery stenosis (aCAD) who are participating in the separate Neuroinflammation in Asymptomatic Carotid Artery Disease study lead by Dr. Ron Lazar (IRB-300007806). The positron emission tomography (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.

Condition or disease Intervention/treatment Phase
Critical Asymptomatic Carotid Artery Disease Non-Critical Asymptomatic Carotid Artery Disease Drug: [18F]DPA-714 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Neuroinflammation in Asymptomatic Carotid Artery Disease - Imaging Substudy
Estimated Study Start Date : August 1, 2022
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cohort 1 - Critical Asymptomatic Carotid Stenosis Group
Critical Stenosis Group: Diagnosis of Asymptomatic Carotid Artery Disease (aCAD) with >70% stenosis or peak systolic velocity on duplex ultrasound (DUS) ≥ 230 cm/s plus computed tomography angiography (CTA) or magnetic resonance angiography (MRA) confirmation.
Drug: [18F]DPA-714
Investigational PET Tracer [18F]DPA-714

Experimental: Cohort 2 - Controls-Non-Critical Asymptomatic Carotid Stenosis Group
<40% carotid stenosis No planned revascularization
Drug: [18F]DPA-714
Investigational PET Tracer [18F]DPA-714




Primary Outcome Measures :
  1. Total volume distribution of the regional time-activity curves from the TSPO- PET Data. [ Time Frame: Pre-study to 48 hours post PET imaging. ]
    The regional time-activity curves from the TSPO-PET data will be combined with image derived input function to provide estimates of total volume distribution (VT) based on a 2-tissue-compartment model (2-TCM) and graphical Logan plot analysis.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Cohort 1 - Critical Asymptomatic Carotid Stenosis Group Inclusion Criteria:

  1. Critical Stenosis Group: Diagnosis of Asymptomatic Carotid Artery Disease (aCAD) with >70% stenosis or peak systolic velocity on DUS ≥ 230 cm/s plus CTA or MRA confirmation.
  2. Participation in University of Alabama at Birmingham (UAB) IRB protocol "Neuroinflammation in Asymptomatic Carotid Artery Disease" (IRB-300007806, PI Lazar).
  3. Male or female age >18 years
  4. English speaking with at least 8th grade education
  5. High affinity binder for TSPO ligands based on genotyping for single nucleotide polymorphism (SNP) rs6971
  6. Planned revascularization for aCAD in >14 days from time of consent

Cohort 2 - Non-Critical Asymptomatic Carotid Stenosis Group Inclusion Criteria:

  1. Participation in UAB IRB protocol "Neuroinflammation in Asymptomatic Carotid Artery Disease" (IRB-300007806, PI Lazar).
  2. <40% carotid stenosis
  3. No planned revascularization
  4. Male or female age 18 or older
  5. English speaking with at least 8th grade education
  6. High affinity binder for TSPO ligands based on genotyping SNP rs6971

Exclusion Criteria:

  1. Contraindication to MRI
  2. Pregnancy or lactation
  3. Previous revascularization for treatment of aCAD
  4. Prior stroke
  5. Severe anemia (blood hemoglobin ≤ 8 mg/dL)
  6. Previously obtained MRI scan with evidence of clinically significant abnormality
  7. History of traumatic head injury defined by loss of consciousness >30 minutes or seizure at the time of the injury
  8. Major depression
  9. Known history of dementia
  10. Serious medical comorbidity that, based on the judgement of the principal investigator, may interfere with study participation
  11. Low or mixed-affinity binding for TSPO ligands based on genotyping for SNP rs6971.

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): NCT05238961


Contacts
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Contact: Evan Hudson 205-934-6499 evanhudson@uabmc.edu

Locations
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United States, Alabama
UAB
Birmingham, Alabama, United States, 35294
Contact: Evan Hudson, BS    205-934-6499    evanhudson@uabmc.edu   
Principal Investigator: Jonathan McConathy, MD,PhD         
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
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Principal Investigator: Jonathan McConathy, MD,PhD University of Alabama at Birmingham
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Responsible Party: Jonathan E McConathy, Official Title: M.D. P.h.D., Director for the Division Molecular Imaging and Therapeutics Affiliation: University of Alabama at Birmingham, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT05238961    
Other Study ID Numbers: R22-019
First Posted: February 14, 2022    Key Record Dates
Last Update Posted: June 30, 2022
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases