RECRUITING

CT Evaluation of Carotid Plaque Components

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Official Title

Validation of Photon Counting/Spectral Computed Tomography Angiography of Carotid Plaque Composition in Patients with Ischemic Stroke

Quick Facts

Study Start:2023-10-01
Study Completion:2028-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05764772

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients with symptomatic carotid stenosis with ipsilateral ischemic infarcts attributable to the carotid disease
  2. * At least 1mm of noncalcified plaque on same side of stroke
  3. * Brain MRI documenting ischemic infarct in distribution attributable to ipsilateral carotid disease
  4. * Patients planned to undergo carotid endarterectomies
  5. * Patients must be able to read and understand English
  6. * Participants must sign the informed consent form
  1. * Exclusion Criteria
  2. * Patients less than 18 years old
  3. * Women who are pregnant and/or nursing

Contacts and Locations

Study Contact

Marisa Sanchez
CONTACT
215-901-9994
Marisa.Sanchez@pennmedicine.upenn.edu
Leeanne Lezotte
CONTACT
856-364-3137
leeanne.lezotte@pennmedicine.upenn.edu

Principal Investigator

Jae W Song
PRINCIPAL_INVESTIGATOR
University of Pennsylvania Hospital

Study Locations (Sites)

University of Pennsylvania Hospital
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: University of Pennsylvania

  • Jae W Song, PRINCIPAL_INVESTIGATOR, University of Pennsylvania Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-01
Study Completion Date2028-12

Study Record Updates

Study Start Date2023-10-01
Study Completion Date2028-12

Terms related to this study

Additional Relevant MeSH Terms

  • Carotid Plaque