RECRUITING

CANF-Comb-II PET-MR in Atherosclerosis Multisite

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Conditions

Carotid AtherosclerosisAsymptomatic Carotid Artery StenosisCarotid Artery AtheromaStrokeTIAVascular DiseaseCardiovascular Disease

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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 learn more about plaque biology in asymptomatic carotid artery stenosis (ACAS) patients through imaging. The main questions it aims to answer are: * To determine the ability of 64Cu-CANF-Comb positron emission tomography (PET) to risk stratify ACAS patients for stroke event, to include transient ischemic attack or remote ipsilateral intervention. * To further understand the role of Natriuretic Peptide Receptor C (NPRC) in the evolution of carotid atherosclerosis. Participants will be asked to undergo a carotid PET-magnetic resonance imaging (MRI) examination to assess whether the carotid atherosclerosis uptake of 64Cu-CANF-Comb as measured by PET-MRI correlates with patient outcomes (stroke, transient ischemic attack, or remote ipsilateral intervention).

Official Title

PET-MR Imaging of Natriuretic Peptide Receptor C (NPR-C) in Carotid Atherosclerosis With Cu[64]-25%-CANF-Comb-II

Quick Facts

Study Start:2023-03-21
Study Completion:2027-05-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05838547

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. * Adults, 18 years of age or older
  2. * Patients who have undergone carotid Doppler/ultrasound imaging which have demonstrated a ≥ 60% diameter carotid artery stenosis.
  3. * The treating surgeon has planned either treatment with optimal medical therapy (OMT) alone, or OMT and carotid endarterectomy (CEA) surgical intervention.
  1. * Inability to receive and sign informed consent.
  2. * Patients with an unstable clinical condition that in the opinion of the Sponsor-Investigator or designee precludes participation in the study.
  3. * Inability to tolerate up to 60 minutes in a supine position with arms down at sides for PET-MR imaging.
  4. * Prior history of CEA or carotid artery stent procedure.
  5. * Past medical history of TIA or stroke within the last 6 months.
  6. * Unwilling to comply with study procedures and/or unable to be available for the duration of the study outlined in the protocol.
  7. * Contraindications to MR imaging (pacemaker, brain aneurysm clips, shrapnel, claustrophobia, etc.).
  8. * Currently pregnant or lactating. All female subjects of childbearing potential must have a documented negative pregnancy test (serum or urine hCG) performed within 24 hours immediately prior to the administration of 64Cu-25%-CANF-Comb or documented post- menopausal defined as the cessation of menses for ≥ 12 months or documentation of having a bilateral oophorectomy and/or hysterectomy.

Contacts and Locations

Study Contact

Molly Mohrman
CONTACT
314-747-4633
mohrmanm@wustl.edu
Pamela Woodard, MD
CONTACT
314-362-7100
woodardp@wustl.edu

Principal Investigator

Pamela Woodard, MD
PRINCIPAL_INVESTIGATOR
Washington University School of Medicine

Study Locations (Sites)

Cedars Sinai Medical Center
Los Angeles, California, 90048
United States
Washington University in St. Louis
Saint Louis, Missouri, 63130-2344
United States

Collaborators and Investigators

Sponsor: Washington University School of Medicine

  • Pamela Woodard, MD, PRINCIPAL_INVESTIGATOR, Washington University School of Medicine

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 Date2023-03-21
Study Completion Date2027-05-31

Study Record Updates

Study Start Date2023-03-21
Study Completion Date2027-05-31

Terms related to this study

Keywords Provided by Researchers

  • Stroke
  • TIA
  • Vascular Disease
  • Cardiovascular Disease

Additional Relevant MeSH Terms

  • Carotid Atherosclerosis
  • Asymptomatic Carotid Artery Stenosis
  • Carotid Artery Atheroma