Carotid PlaqueNCT05764772
CT Evaluation of Carotid Plaque Components
An observational study of Carotid Plaque, run by University of Pennsylvania at 1 site in United States.
Trial summary
The goal of this observational study is to validate the diagnostic performance of photon counting/spectral CT to distinguish tissue components in ischemic stroke with MRI, semi-automated segmentation software or histology as the reference standard. The main question[s] it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Plaque
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2023to Dec 2028
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Patients presenting with acute stroke or transient ischemic attacks and stenosis of the ipsilateral carotid artery will be identified and eligible patients will be screened and consented for study participation in a multi-disciplinary effort by Vascular Neurology (contact: Dr. Brett Cucchiara), Vascular Surgery (contact: Dr. Grace Wang), and Diagnostic Radiology (contact: Dr. Jae W. Song).
Who may be able to join
- Patients with symptomatic carotid stenosis with ipsilateral ischemic infarcts attributable to the carotid disease
- At least 1mm of noncalcified plaque on same side of stroke
- Brain MRI documenting ischemic infarct in distribution attributable to ipsilateral carotid disease
- Patients planned to undergo carotid endarterectomies
- Patients must be able to read and understand English
- Participants must sign the informed consent form
Who cannot join
- Patients less than 18 years old
- Women who are pregnant and/or nursing
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, 19104
Marisa Sanchez, 215-901-9994, Marisa.Sanchez@pennmedicine.upenn.edu
Leeanne Lezotte, 215-615-5462, leeanne.lezotte@pennmedicine.upenn.edu
About this study
Official title: Validation of Photon Counting/Spectral Computed Tomography Angiography of Carotid Plaque Composition in Patients With Ischemic Stroke
The goal of this observational study is to validate the diagnostic performance of photon counting/spectral CT to distinguish tissue components in ischemic stroke with MRI, semi-automated segmentation software or histology as the reference standard.
The main question[s] it aims to answer are:
Read more
- Presence or absence of calcium, hemorrhage, and lipid plaque components as determined on CT will be confirmed with carotid MRI, segmentation quantitative (e.g., volume) output from segmentation software, or histologic staining.
- Volumes of hemorrhage, lipid, and calcium components will be measured to determine plaque phenotype and correlated with ipsilateral intracranial stroke burden.
Participants will be asked to do the following:
Aim 1:
- 1 Photon counting/spectral CT angiography of the neck
- 1 Research Carotid/Neck MRI of the carotid arteries (if eligible)
Aim 2:
- 1 Research Carotid/Neck MRI of the carotid arteries (if eligible)
- 1 Photon counting/spectral CT angiography of the neck
- 1 Carotid plaque tissue from participants surgery will be retrieved, imaged, and stained (if eligible)
Read the detailed description
Independent of the degree of stenosis, specific features of carotid plaque composition are associated with a high risk of thromboembolic and recurrent stroke. Many lines of evidence show a significant association between the presence of intraplaque hemorrhage and lipid rich necrotic core in carotid plaque independent of vessel stenosis in patients with ipsilateral ischemic infarcts. In fact, up to 17% of ischemic strokes are classified as embolic stroke of undetermined source (ESUS) after a comprehensive diagnostic work-up. A subset of these patients have stroke due to mildly stenotic plaque composed of high-risk non-calcified carotid plaque components that are presently difficult to distinguish by noninvasive conventional imaging tests. Presently first-line imaging of acute stroke patients is computed tomography angiography (CTA) of the head and neck. Although conventional CTA provides information about stenosis, it lacks the ability to distinguish tissue components with similar attenuation curves (e.g., lipid and intraplaque hemorrhage). Thus, invaluable diagnostic information is lost due to limitations of conventional CTA. By contrast, photon-counting/spectral CT is a novel technology that can identify material-specific characteristics and identify plaque components (e.g., iron/hemorrhage, lipid, and calcium) based on the specific behavior of these materials at different photon energy levels.
The investigators propose testing the diagnostic performance of this new CT technology to detect different plaque components in subjects who are medically managed by carotid MRI or postprocessing PCCT images using a semi-automated carotid plaque segmentation software. The investigators also propose testing the diagnostic performance of this new CT technology in patients undergoing carotid endarterectomy revascularization surgery as standard of care with carotid MRI and histologic validation of the resected plaque tissue (ground truth).
Accurate detection of these high-risk noncalcified plaque components by noninvasive imaging methods would be of great value to identifying a patient population at highest risk for embolic stroke from carotid disease.
- Conditions
- Carotid Plaque
What is being measured
The primary outcome is the main question the study is designed to answer.
To validate the diagnostic performance of photon counting/spectral CT
Presence or absence of calcium, hemorrhage, and lipid plaque components as determined on CT will be confirmed with carotid MRI, segmentation quantitative (e.g., volume) output from segmentation software, or histologic staining.
Measured: 3years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start1 Oct 2023
- Primary completionAug 2026 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid PlaqueStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jae W. Song, MD, MS, University of Pennsylvania
- Investigators
- Jae W Song, Principal investigator, University of Pennsylvania Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05764772
- Sponsor's protocol ID
- 852646
- Status last verified
- Nov 2025
- First submitted
- 10 Feb 2023
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Photon Counting/Spectral Computed Tomography Angiography of Carotid Plaque Composition in Patients With Ischemic Stroke
- ClinicalTrials.gov ID
- NCT05764772
- Acronym / sponsor ID
- 852646
- Conditions
- Carotid Plaque
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 13 Mar 2023 (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.
The goal of this observational study is to validate the diagnostic performance of photon counting/spectral CT to distinguish tissue components in ischemic stroke with MRI, semi-automated segmentation software or histology as the reference standard.
The main question[s] it aims to answer are:
- Presence or absence of calcium, hemorrhage, and lipid plaque components as determined on CT will be confirmed with carotid MRI, segmentation quantitative (e.g., volume) output from segmentation software, or histologic staining.
- Volumes of hemorrhage, lipid, and calcium components will be measured to determine plaque phenotype and correlated with ipsilateral intracranial stroke burden.
Participants will be asked to do the following:
Aim 1:
- 1 Photon counting/spectral CT angiography of the neck
- 1 Research Carotid/Neck MRI of the carotid arteries (if eligible)
Aim 2:
- 1 Research Carotid/Neck MRI of the carotid arteries (if eligible)
- 1 Photon counting/spectral CT angiography of the neck
- 1 Carotid plaque tissue from participants surgery will be retrieved, imaged, and stained (if eligible)
Detailed description
Independent of the degree of stenosis, specific features of carotid plaque composition are associated with a high risk of thromboembolic and recurrent stroke. Many lines of evidence show a significant association between the presence of intraplaque hemorrhage and lipid rich necrotic core in carotid plaque independent of vessel stenosis in patients with ipsilateral ischemic infarcts. In fact, up to 17% of ischemic strokes are classified as embolic stroke of undetermined source (ESUS) after a comprehensive diagnostic work-up. A subset of these patients have stroke due to mildly stenotic plaque composed of high-risk non-calcified carotid plaque components that are presently difficult to distinguish by noninvasive conventional imaging tests. Presently first-line imaging of acute stroke patients is computed tomography angiography (CTA) of the head and neck. Although conventional CTA provides information about stenosis, it lacks the ability to distinguish tissue components with similar attenuation curves (e.g., lipid and intraplaque hemorrhage). Thus, invaluable diagnostic information is lost due to limitations of conventional CTA. By contrast, photon-counting/spectral CT is a novel technology that can identify material-specific characteristics and identify plaque components (e.g., iron/hemorrhage, lipid, and calcium) based on the specific behavior of these materials at different photon energy levels.
The investigators propose testing the diagnostic performance of this new CT technology to detect different plaque components in subjects who are medically managed by carotid MRI or postprocessing PCCT images using a semi-automated carotid plaque segmentation software. The investigators also propose testing the diagnostic performance of this new CT technology in patients undergoing carotid endarterectomy revascularization surgery as standard of care with carotid MRI and histologic validation of the resected plaque tissue (ground truth).
Accurate detection of these high-risk noncalcified plaque components by noninvasive imaging methods would be of great value to identifying a patient population at highest risk for embolic stroke from carotid disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting with acute stroke or transient ischemic attacks and stenosis of the ipsilateral carotid artery will be identified and eligible patients will be screened and consented for study participation in a multi-disciplinary effort by Vascular Neurology (contact: Dr. Brett Cucchiara), Vascular Surgery (contact: Dr. Grace Wang), and Diagnostic Radiology (contact: Dr. Jae W. Song).
Key inclusion criteria (6 listed)
- Patients with symptomatic carotid stenosis with ipsilateral ischemic infarcts attributable to the carotid disease
- At least 1mm of noncalcified plaque on same side of stroke
- Brain MRI documenting ischemic infarct in distribution attributable to ipsilateral carotid disease
- Patients planned to undergo carotid endarterectomies
- Patients must be able to read and understand English
Key exclusion criteria (2 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To validate the diagnostic performance of photon counting/spectral CT
Time frame: 3years
Presence or absence of calcium, hemorrhage, and lipid plaque components as determined on CT will be confirmed with carotid MRI, segmentation quantitative (e.g., volume) output from segmentation software, or histologic staining.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
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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.
Jae W Song principal investigator
University of Pennsylvania Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carotid Plaque, run by University of Pennsylvania at 1 site in United States.
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 6 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marisa Sanchez (215-901-9994, Marisa.Sanchez@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To validate the diagnostic performance of photon counting/spectral CT (time frame: 3years). 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 25 Nov 2025.