Critical Asymptomatic Carotid Artery DiseasePhase 1NCT05238961
Neuroinflammation in Asymptomatic Carotid Artery Disease - Imaging Substudy
A Phase 1 study testing [18F]DPA-714 in people with Critical Asymptomatic Carotid Artery Disease and Non-Critical Asymptomatic Carotid Artery Disease, run by University of Alabama at Birmingham.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Asymptomatic Carotid Artery Disease, Non-Critical Asymptomatic Carotid Artery Disease
- What is being tested?
- [18F]DPA-714
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2028to Apr 2028
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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.
About this study
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
- Being tested
- [18F]DPA-714
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]DPA-714Drug
Investigational PET Tracer [18F]DPA-714
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: [18F]DPA-714 |
| Cohort 2 - Controls-Non-Critical Asymptomatic Carotid Stenosis Group | Experimental | <40% carotid stenosis No planned revascularization Receives: Drug: [18F]DPA-714 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre-study to 48 hours post PET imaging.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start1 Apr 2028 (estimated)
- Primary completionApr 2028 (estimated)
- Study completionApr 2028 (estimated)
Why it stopped: Recruitment issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical Asymptomatic Carotid Artery DiseaseStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan E McConathy, University of Alabama at Birmingham
- Investigators
- Jonathan McConathy, MD,PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05238961
- Sponsor's protocol ID
- IRB-300008773 R22-019
- Other IDs
- UAB
- Status last verified
- Feb 2026
- First submitted
- 7 Feb 2022
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroinflammation in Asymptomatic Carotid Artery Disease - Imaging Substudy
- ClinicalTrials.gov ID
- NCT05238961
- Acronym / sponsor ID
- IRB-300008773 R22-019
- Conditions
- Critical Asymptomatic Carotid Artery Disease, Non-Critical Asymptomatic Carotid Artery Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Recruitment issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 1 Apr 2028 (estimated)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 14 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 - Critical Asymptomatic Carotid Stenosis Group | Experimental | Drug: [18F]DPA-714Critical 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. |
| Cohort 2 - Controls-Non-Critical Asymptomatic Carotid Stenosis Group | Experimental | Drug: [18F]DPA-714<40% carotid stenosis No planned revascularization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (11 listed)
- Contraindication to MRI
- Pregnancy or lactation
- Previous revascularization for treatment of aCAD
- Prior stroke
- Severe anemia (blood hemoglobin ≤ 8 mg/dL)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [18F]DPA-714Investigational PET Tracer [18F]DPA-714 | Drug | Cohort 1 - Critical Asymptomatic Carotid Stenosis Group, Cohort 2 - Controls-Non-Critical Asymptomatic Carotid Stenosis Group |
Primary outcome
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan McConathy, MD,PhD principal investigator
University of Alabama at Birmingham
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [18F]DPA-714 in people with Critical Asymptomatic Carotid Artery Disease and Non-Critical Asymptomatic Carotid Artery Disease, run by University of Alabama at Birmingham.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total volume distribution of the regional time-activity curves from the TSPO- PET Data. (time frame: Pre-study to 48 hours post PET imaging.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.