Imaging of Unstable Carotid Plaque in Patient Referred to Endarterectomy (CAROTEP)

January 9, 2020 updated by: University Hospital, Caen

Assessment of Unstable Carotid Plaque Using PET and MR Imaging in Patient Referred to Endarterectomy: The CAROTEP Study

This study will assess unstable plaque imaging features by using high resolution MR imaging and Sodium Fluoride F-18 PET. This is a comparative study between symptomatic and asymptomatic patient referred to carotid endateriectomy, with reference to pathologic analysis of plaque components

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age over 18 years old
  • Health care system affiliation
  • Referred to carotid endarterectomy

  • Symptomatic patients:

    • Carotid stenosis between 70 and 99% (NASCET criteria)
    • TIA or minor stroke attack (RANKIN ≤ 3)

  • Asymptomatic patients:

    • Carotid stenosis between 70 and 99% (NASCET criteria)
    • No symptoms
  • Patient who has been informed of the study and has given his/her informed consent

Exclusion Criteria:

  • Contra indication to MRI
  • Renal failure (clearance < 30ml/mn)
  • Patient with active inflammatory disease
  • History of cancer
  • Pregnancy or lactation
  • Patient with carotid disease treated by fibrinolysis
  • Patient under guardianship, or unable to understand the purpose of the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: symptomatic
Drug: Sodium fluoride F-18 PET imaging
prior to surgical endarterectomy each patient will undergo sodium fluoride F-18 PET imaging
Active Comparator: asymptomatic
Drug: Sodium fluoride F-18 PET imaging
prior to surgical endarterectomy each patient will undergo sodium fluoride F-18 PET imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
carotid F18-NaF uptake
Time Frame: baseline
do the symptomatic patients have a higher F18-NaF uptake compared to asymptomatic patients? at pre-operative examination
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
comparaison of F18-NaF PET and Carotid MRI
Time Frame: baseline
comparaison between F18-NaF uptake and MR features of plaque instability at pre-operative examination
baseline
F18-NaF PET uptake
Time Frame: baseline
comparaison between F18-NaF uptake at pre-operative imaging
baseline
histology
Time Frame: baseline
comparaison between histology at post-operative histologic analysis
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Caen

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 Major Dates

Study Start (Actual)

September 3, 2018

Primary Completion (Anticipated)

June 1, 2020

Study Completion (Anticipated)

June 1, 2021

Study Registration Dates

First Submitted

April 14, 2017

First Submitted That Met QC Criteria

November 22, 2017

First Posted (Actual)

November 27, 2017

Study Record Updates

Last Update Posted (Actual)

January 13, 2020

Last Update Submitted That Met QC Criteria

January 9, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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