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

NCT ID: NCT04466787

Last Updated: 2024-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-20
• Study Completion Date: 2021-11-24

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Spectral Photon Counting Computed Tomography (SPCCT)

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

Group Type: EXPERIMENTAL

Spectral Photon Counting Computed Tomography (SPCCT)

Intervention Type: 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.

Dual Energy CT (DECT)

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

Group Type: ACTIVE_COMPARATOR

Dual Energy CT (DECT)

Intervention Type: 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

Interventions

Spectral Photon Counting Computed Tomography (SPCCT)

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.

Intervention Type: DIAGNOSTIC_TEST

Dual Energy CT (DECT)

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philippe DOUEK, Pr

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

Louis Pradel cardiovascular Hospital

Bron, , France

Countries

France

Other Identifiers

2018-A02696-49

Identifier Type: OTHER

Identifier Source: secondary_id

69HCL18_0412

Identifier Type: -

Identifier Source: org_study_id