Comparison of Spectral Photon Counting CT (SPCCT) With Dual Energy CT (DECT) and Magnetic Resonance Imaging (MRI) for Plaque and Lumen Carotid Arteries Evaluation.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Intra Plaque Hemorrhage (IPH) in mm² identified with DECT
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
盲法说明
The images will be read without knowing the CT scan used
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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);
- •Patient under guardianship, curators or safeguard of justice.
结局指标
主要结局
Intra Plaque Hemorrhage (IPH) in mm² identified with DECT
时间窗: 1 month
measurement of the height and thickness of surface of the plaque's components
Intra Plaque Hemorrhage (IPH) in mm² identified with SPCCT
时间窗: 1 month
measurement of the height and thickness of surface of the plaque's components
Lipid Necrotic Core (LNC) in mm² identified with DECT
时间窗: 1 month
measurement of the height and thickness of surface of the plaque's components
Fibrous Cap Ulceration (FCU) in mm² identified with DECT
时间窗: 1 month
measurement of the height and thickness of surface of the plaque's components
Lipid Necrotic Core (LNC) in mm² identified with SPCCT
时间窗: 1 month
measurement of the height and thickness of surface of the plaque's components
Lipid Necrotic Core (LNC) in mm² identified with histology
时间窗: 1 month
measurement of the height and thickness of surface of the plaque's components
Intra Plaque Hemorrhage (IPH) identified with histology
时间窗: 1 month
measurement of the height and thickness of surface of the plaque's components
Fibrous Cap Ulceration (FCU) in mm² identified with SPCCT
时间窗: 1 month
measurement of the height and thickness of surface of the plaque's components
Fibrous Cap Ulceration (FCU) in mm² identified with histology
时间窗: 1 month
measurement of the height and thickness of surface of the plaque's components
次要结局
- radiation dose received during DECT(1 month)
- radiation dose received during SPCCT(1 month)
- Tolerance to MRI assessed by a tolerance survey(1 month)
- Number of irregularities identified with DECT(1 month)
- Tolerance to DECT assessed by a tolerance survey(1 month)
- Assessable vascular segments with lack of image artifacts(1 month)
- Tolerance to SPCCT assessed by a tolerance survey(1 month)
- Number of irregularities identified with MRI(1 month)
- Number of irregularities identified with SPCCT(1 month)
- Number of ulcerations identified with SPCCT(1 month)
- Number of ulcerations identified with DECT(1 month)
- Number of ulcerations identified with MRI(1 month)