Recruiting

Observational Study

Sponsor:

University of Pennsylvania

Code:

NCT05764772

Conditions

Carotid Plaque

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief 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. 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.
2. 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)

Conditions

Carotid Plaque

Study ID

NCT05764772

Start date

Oct 1, 2023

Status verified date

Nov, 2025

Completion date

Dec, 2028

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Exclusion Criteria

  • Patients less than 18 years old
  • Women who are pregnant and/or nursing

Study Design

Enrollment

70 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • To validate the diagnostic performance of photon counting/spectral CT [ Time Frame: 3years ]

Central Contacts and Locations

Locations

University of Pennsylvania Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Principal Investigator:

Jae Song

More Information

Sponsor

University of Pennsylvania

Last update posted

Nov 25, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2025-11-25.