Neuroinflammation in Asymptomatic Carotid Artery Disease - Imaging Substudy

NCT05238961 | Withdrawn Phase 1 DMC FDA Drug

• 2 other identifiers: R22-019UAB
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Asymptomatic Carotid Artery Disease; Non-Critical Asymptomatic Carotid Artery Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  Pre-study to 48 hours post PET imaging.

Study Arms (2)

Cohort 1 - Critical Asymptomatic Carotid Stenosis Group

EXPERIMENTAL

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

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

EXPERIMENTAL

\<40% carotid stenosis No planned revascularization

Drug: [18F]DPA-714

Interventions

[18F]DPA-714 DRUG

Investigational PET Tracer \[18F\]DPA-714

Cohort 1 - Critical Asymptomatic Carotid Stenosis Group; Cohort 2 - Controls-Non-Critical Asymptomatic Carotid Stenosis Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Officials

• Jonathan McConathy, MD,PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Official Title: M.D. P.h.D., Director for the Division Molecular Imaging and Therapeutics Affiliation: University of Alabama at Birmingham

Study Record Dates

• First Submitted: February 7, 2022
• First Posted: February 14, 2022
• Study Start (Estimated): April 1, 2028
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: February 20, 2026

Record last verified: 2026-02

Locations

US (1)