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Brain scan study to detect hidden inflammation in silent artery disease

NCT ID NCT05238961

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study was designed to use a special PET scan to measure brain inflammation in people with asymptomatic carotid artery disease (narrowing of neck arteries without symptoms). It aimed to compare inflammation levels between those with high-grade and low-grade narrowing. However, the study was withdrawn before enrolling any participants, so no results were obtained.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Expected to start

Apr 2028

An estimate. Start dates often move.

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.