Comparison of Spectral Photon Counting CT (SPCCT) With Dual Energy CT (DECT) and Magnetic Resonance Imaging (MRI) for Plaque and Lumen Carotid Arteries Evaluation

Last updated: July 12, 2024
Sponsor: Hospices Civils de Lyon
Overall Status: Completed

Phase

N/A

Condition

N/A

Treatment

Dual Energy CT (DECT)

Spectral Photon Counting Computed Tomography (SPCCT)

Clinical Study ID

NCT04466787
69HCL18_0412
2018-A02696-49
  • Ages > 18
  • All Genders

Study Summary

In this study, the investigator propose to determine the efficiency of a new and more sophisticated imaging prototype, the Spectral Photon Counting Computed Tomography (SPCCT), at characterizing vulnerable plaques and luminal stenosis in Carotid Atherosclerosis patients compared to DECT (Dual Energy CT) and MRI (Magnetic Resonance Imaging) which are used in current practice

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female subjects of any ethnic background, aged > 18 years

  • Any of the following known or suspected supra-aortic arterial disease based on :Prior stroke; Transient Ischemic Attack; Amaurosis Fugax; Referred for evaluation ofany supra-aortic vessel; Follow-up for a stent in a supra-aortic vessel; Priorimaging ultrasounds study showing > ou = 50 % stenosis of a supra-aortic vesselsegment (within 60 days before consent)

  • Patient undergoing surgery within one month of carotid plaque evaluation

  • Willingness and ability to follow directions and complete all study proceduresspecified in the protocol

  • Pre-menopausal women only : Negative urinary pregnancy test on the day of imagingbefore the administration of study drug

  • Patient has accepted to participate to the study and has signed the written consent

  • Patient is affiliated to social security

Exclusion

Exclusion Criteria:

  • Contraindication to MRI examinations (e.g. inability to hold breath, severearrhythmias, very low cardiac output, severe claustrophobia, metallic devices notapproved for MRI such as defibrillators, pacemaker, heart valve prostheses, cochlearimplants, neuro-stimulators, implanted automated injection device, intraocularmetallic foreign bodies, neurosurgical and vascular clips);

  • Contraindication to the use of iodine and gadolinium containing contrast media (including subjects with suspicion for/or known to have NSF);- History of severeallergic or anaphylactic reaction to any allergen including drugs and contrastagents (as judged by the investigator, taking into account the intensity of theevent);

  • Estimated Glomerular Filtration Rate (eGFR) value < 30 mL/min/1.73 m2 derived from aserum creatinine result within 1 month before the imaging;

  • Any subject on hemodialysis or peritoneal dialysis (Note: If there are multiplecreatinine values, the values obtained prior to and closest to the time of theexamination should be used);

  • Acute renal insufficiency of any intensity, either due to hepato-renal syndrome oroccurring in the per-operative liver transplantation period;

  • Known subject history of severe cardiovascular disease (e.g. acute myocardialinfarction [< 14 days], unstable angina, congestive heart failure New York HeartAssociation class IV) or known long QT syndrome;

  • Suspected clinical instability or unpredictability of the clinical course during thestudy period (e.g. due to previous surgery);

  • Scheduled or potentially expected for the period between the SPCCT or DECT and MRI:Any procedure that may alter the MRI or CT interpretation; Any interventional orsurgical procedure involving the supra-aortic vessels.

  • Pregnant or nursing (including pumping for storage and feeding); 11. Patient underguardianship, curators or safeguard of justice.

Study Design

Total Participants: 22
Treatment Group(s): 2
Primary Treatment: Dual Energy CT (DECT)
Phase:
Study Start date:
June 20, 2019
Estimated Completion Date:
November 24, 2021

Connect with a study center

  • Louis Pradel cardiovascular Hospital

    Bron,
    France

    Site Not Available

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