CT Evaluation of Carotid Plaque Components

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
University of Pennsylvania
Study ID
NCT05764772
Status
Recruiting

Conditions

  • Carotid Plaque

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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)

Key Dates

Start date
Oct 1, 2023
Status verified
Nov 2025
Primary completion
Aug 31, 2026
Completion
Dec 31, 2028

Study Design

Enrollment
70 participants (estimated)

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Pennsylvania HospitalPhiladelphiaPennsylvania19104
Marisa Sanchez
215-901-9994
Leeanne Lezotte
215-615-5462
Jae Song (PRINCIPAL_INVESTIGATOR)

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