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Neuroinflammation in Asymptomatic Carotid Artery Disease - Imaging Substudy

Primary Purpose

Critical Asymptomatic Carotid Artery Disease, Non-Critical Asymptomatic Carotid Artery Disease

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
[18F]DPA-714
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Critical Asymptomatic Carotid Artery Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UABRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Cohort 1 - Critical Asymptomatic Carotid Stenosis Group

Cohort 2 - Controls-Non-Critical Asymptomatic Carotid Stenosis Group

Arm Description

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.

<40% carotid stenosis No planned revascularization

Outcomes

Primary Outcome Measures

Total volume distribution of the regional time-activity curves from the TSPO- PET Data.
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.

Secondary Outcome Measures

Full Information

First Posted
February 7, 2022
Last Updated
December 13, 2022
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT05238961
Brief Title
Neuroinflammation in Asymptomatic Carotid Artery Disease - Imaging Substudy
Official Title
Neuroinflammation in Asymptomatic Carotid Artery Disease - Imaging Substudy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2023 (Anticipated)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Asymptomatic Carotid Artery Disease, Non-Critical Asymptomatic Carotid Artery Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1 - Critical Asymptomatic Carotid Stenosis Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Cohort 2 - Controls-Non-Critical Asymptomatic Carotid Stenosis Group
Arm Type
Experimental
Arm Description
<40% carotid stenosis No planned revascularization
Intervention Type
Drug
Intervention Name(s)
[18F]DPA-714
Intervention Description
Investigational PET Tracer [18F]DPA-714
Primary Outcome Measure Information:
Title
Total volume distribution of the regional time-activity curves from the TSPO- PET Data.
Description
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.
Time Frame
Pre-study to 48 hours post PET imaging.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Cohort 1 - Critical Asymptomatic Carotid Stenosis Group Inclusion Criteria: 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. Participation in University of Alabama at Birmingham (UAB) IRB protocol "Neuroinflammation in Asymptomatic Carotid Artery Disease" (IRB-300007806, PI Lazar). Male or female age >18 years English speaking with at least 8th grade education High affinity binder for TSPO ligands based on genotyping for single nucleotide polymorphism (SNP) rs6971 Planned revascularization for aCAD in >14 days from time of consent Cohort 2 - Non-Critical Asymptomatic Carotid Stenosis Group Inclusion Criteria: Participation in UAB IRB protocol "Neuroinflammation in Asymptomatic Carotid Artery Disease" (IRB-300007806, PI Lazar). <40% carotid stenosis No planned revascularization Male or female age 18 or older English speaking with at least 8th grade education High affinity binder for TSPO ligands based on genotyping SNP rs6971 Exclusion Criteria: Contraindication to MRI Pregnancy or lactation Previous revascularization for treatment of aCAD Prior stroke Severe anemia (blood hemoglobin ≤ 8 mg/dL) Previously obtained MRI scan with evidence of clinically significant abnormality History of traumatic head injury defined by loss of consciousness >30 minutes or seizure at the time of the injury Major depression Known history of dementia Serious medical comorbidity that, based on the judgement of the principal investigator, may interfere with study participation Low or mixed-affinity binding for TSPO ligands based on genotyping for SNP rs6971.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Evan Hudson
Phone
205-934-6499
Email
evanhudson@uabmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan McConathy, MD,PhD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
UAB
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Evan Hudson, BS
Phone
205-934-6499
Email
evanhudson@uabmc.edu
First Name & Middle Initial & Last Name & Degree
Jonathan McConathy, MD,PhD

12. IPD Sharing Statement

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Neuroinflammation in Asymptomatic Carotid Artery Disease - Imaging Substudy

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