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

NCT04466787 | Completed

• 2 other identifiers: 69HCL18_04122018-A02696-49
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Supra-Aortic Stenosis

Keywords

diagnostic; carotid plaque; SPCCT

Outcome Measures

Primary Outcomes (9)

• Lipid Necrotic Core (LNC) in mm² identified with SPCCT

  measurement of the height and thickness of surface of the plaque's components

  1 month

• Lipid Necrotic Core (LNC) in mm² identified with DECT

  measurement of the height and thickness of surface of the plaque's components

  1 month

• Lipid Necrotic Core (LNC) in mm² identified with histology

  measurement of the height and thickness of surface of the plaque's components

  1 month

• Intra Plaque Hemorrhage (IPH) in mm² identified with SPCCT

  measurement of the height and thickness of surface of the plaque's components

  1 month

• Intra Plaque Hemorrhage (IPH) in mm² identified with DECT

  measurement of the height and thickness of surface of the plaque's components

  1 month

• Intra Plaque Hemorrhage (IPH) identified with histology

  measurement of the height and thickness of surface of the plaque's components

  1 month

• Fibrous Cap Ulceration (FCU) in mm² identified with SPCCT

  measurement of the height and thickness of surface of the plaque's components

  1 month

• Fibrous Cap Ulceration (FCU) in mm² identified with DECT

  measurement of the height and thickness of surface of the plaque's components

  1 month

• Fibrous Cap Ulceration (FCU) in mm² identified with histology

  measurement of the height and thickness of surface of the plaque's components

  1 month

Secondary Outcomes (12)

• Number of irregularities identified with SPCCT

  1 month

• Number of irregularities identified with DECT

  1 month

• Number of irregularities identified with MRI

  1 month

• Number of ulcerations identified with SPCCT

  1 month

• Number of ulcerations identified with DECT

  1 month

Study Arms (2)

Spectral Photon Counting Computed Tomography (SPCCT)

EXPERIMENTAL

The randomized SPCCT patient will have this CT scan and an MRI before surgery. The plaque carotid will be collected for histological analysis

Diagnostic Test: Spectral Photon Counting Computed Tomography (SPCCT)

Dual Energy CT (DECT)

ACTIVE COMPARATOR

The randomized DECT patient will have this CT scan and an MRI before surgery. The plaque carotid will be collected for histological analysis

Diagnostic Test: Dual Energy CT (DECT)

Interventions

Spectral Photon Counting Computed Tomography (SPCCT) DIAGNOSTIC_TEST

The acquisition for the assessment of the brain parenchyma and for the evaluation of the cervical and intracranial arteries will be performed without and with iodine based contrast media, respectively. The same parameters will be used for both conditions but for a large volume, from the aortic arch to the top of the head. The iodinate contrast agent's injection (Iomeron 400, Bracco Imaging France) will be performed at 5mL/s into an 18G catheter, followed by a 20 mL saline flush that will be injected at the same rate. The bolus volume will be determined according to the patient's body weight : 70 mL for patients \< 80 kg and 1 mL/kg for patients \> 80 kg, with a maximum of 90 mL. The SPCCT scanner is a prototype spectral photon-counting computed tomography system derived from a modified clinical CT system with a field of View (FOV) of 168 mm in-plane, and a z-coverage of 2 mm.

Spectral Photon Counting Computed Tomography (SPCCT)

Dual Energy CT (DECT) DIAGNOSTIC_TEST

The acquisition for the assessment of the brain parenchyma and for the evaluation of the cervical and intracranial arteries will be performed without and with iodine based contrast media, respectively. The same parameters will be used for both conditions but for a large volume, from the aortic arch to the top of the head. The iodinate contrast agent's injection (Iomeron 400, Bracco Imaging France) will be performed at 5mL/s into an 18G catheter, followed by a 20 mL saline flush that will be injected at the same rate. The bolus volume will be determined according to the patient's body weight : 70 mL for patients \< 80 kg and 1 mL/kg for patients \> 80 kg, with a maximum of 90 mL. DECT : IQon, Philips

Dual Energy CT (DECT)

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 of any supra-aortic vessel; Follow-up for a stent in a supra-aortic vessel; Prior imaging ultrasounds study showing \> ou = 50 % stenosis of a supra-aortic vessel segment (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 procedures specified in the protocol
• Pre-menopausal women only : Negative urinary pregnancy test on the day of imaging before 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

You may not qualify if:

• Contraindication to MRI examinations (e.g. inability to hold breath, severe arrhythmias, very low cardiac output, severe claustrophobia, metallic devices not approved for MRI such as defibrillators, pacemaker, heart valve prostheses, cochlear implants, neuro-stimulators, implanted automated injection device, intraocular metallic 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 severe allergic or anaphylactic reaction to any allergen including drugs and contrast agents (as judged by the investigator, taking into account the intensity of the event);
• Estimated Glomerular Filtration Rate (eGFR) value \< 30 mL/min/1.73 m2 derived from a serum creatinine result within 1 month before the imaging;
• Any subject on hemodialysis or peritoneal dialysis (Note: If there are multiple creatinine values, the values obtained prior to and closest to the time of the examination should be used);
• Acute renal insufficiency of any intensity, either due to hepato-renal syndrome or occurring in the per-operative liver transplantation period;
• Known subject history of severe cardiovascular disease (e.g. acute myocardial infarction \[\< 14 days\], unstable angina, congestive heart failure New York Heart Association class IV) or known long QT syndrome;
• Suspected clinical instability or unpredictability of the clinical course during the study 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 or surgical procedure involving the supra-aortic vessels.
• Pregnant or nursing (including pumping for storage and feeding); 11. Patient under guardianship, curators or safeguard of justice.

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Louis Pradel cardiovascular Hospital

Bron, France

Location

MeSH Terms

Conditions

Aortic Stenosis, Supravalvular; Disease

Condition Hierarchy (Ancestors)

Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Philippe DOUEK, Pr

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The images will be read without knowing the CT scan used
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2020
• First Posted: July 10, 2020
• Study Start: June 20, 2019
• Primary Completion: November 24, 2021
• Study Completion: November 24, 2021
• Last Updated: July 15, 2024

Record last verified: 2024-07

Locations

FR (1)