Evaluation of MRI Sequences for Ultra-rapid Acquisition of Bile Ducts Images
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- Global quality of the images evaluated with a Likert score
研究概览
简要总结
The Institute of Imaged-Guided Surgery (IHU Strasbourg) has two clinical Magnetic Resonance Imaging (MRI) scanners, one with a 3T (3 Teslas) magnetic field used for diagnosis, the other with a magnetic field of 1,5T (1,5 Teslas) used for the interventional (Pre / per / postoperative).
The reference for the visualization of the biliary and pancreatic ducts is a relatively long sequence that needs a breathing-synchronized acquisition leading to artefacts on the images (blur effect).
In order to reduce and/or standardize the acquisition time as well as to limit artefacts, accelerated sequences are developed. Such sequence is available in France recently in the form of WIP Siemens (Work In Progress: sequence in test phase at manufacturer to be marketed in the short or medium term on clinical machines). It incorporates a Compressed Sensing (CS) acquisition scheme allowing the acquisition of a 3D (3 dimensions) sequence similar to the usual sequence by drastically reducing the acquisition time, the sequence CS-SPACE. This sequence exists in two forms:
- An ultra-rapid sequence acquired in apnea
- An accelerated sequence but remaining synchronized with the breath. The study carried out here on a large number of patients, with two different magnetic fields, applied routinely for diagnosis or anticipation of surgery, could be used by the community of radiologists, hepatogastroenterologists and also digestive surgeons Hepatobiliary.
详细描述
The Institute of Imaged-Guided Surgery (IHU Strasbourg) has two clinical MRIs, one with a 3T (Teslas) magnetic field used for diagnosis, the other with a magnetic field of 1,5T (Teslas) used for the interventional (Pre / per / postoperative).
Cholangiopancreatography by MRI (or bili-MRI) accounts for about 25% of MRI examinations at the IHU and is used for the diagnosis of pathologies affecting the bile ducts (lithiasis pathology, cholangitis, tumoral pathology of the bile ducts) and the pancreas (search for a causal pathology to pancreatitis (calculus), ductal pathology, ductal study in tumor pathology). It can be done in preoperative context (cholecystectomy) for research of an associated calculus in the bile ducts, or for an anatomical analysis of the bile ducts (possible anatomical variants ...).
The reference for the visualization of the biliary and pancreatic ducts is a very heavily weighted T2 3D SPACE sequence. A 3D volume is obtained in which they appear in white, and the projection of this volume makes it possible to visualize the entire tract. This sequence is relatively long and needs a breathing-synchronized acquisition. The time of acquisition is then very variable from one patient to another (4 to 8 minutes). This extended acquisition time in addition to the variability of rhythm and respiratory profile can lead to artefacts on the images (blur effect). These are the limits of the respiratory synchronization that triggers acquisition by referring to the position of the liver dome which is not perfectly reproducible from a breathing cycle to the other, potentially degrading the appearance of the bile ducts and the reliability of the diagnosis.
A solution that makes it possible to reduce and / or standardize the acquisition time as well as to limit artefacts is to use an accelerated sequence. Such a sequence is available in France recently in the form of WIP Siemens (Work In Progress: sequence in test phase at manufacturer to be marketed in the short or medium term on clinical machines). It incorporates a Compressed Sensing (CS) acquisition scheme allowing the acquisition of a 3D sequence similar to the usual sequence by drastically reducing the acquisition time, the sequence CS-SPACE. This sequence exists in two forms:
- An ultra-rapid sequence acquired in apnea
- An accelerated sequence but remaining synchronized with the breath. This sequence has been shown to provide comparable, if not better, results to those obtained with the usual sequence in terms of image quality and visualization of structures, but these results were only obtained at 3T and for a reduced cohort of patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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 over 18 years old
- •Patient for whom MRI is required for the diagnosis or follow-up of a pathology
- •Patient able to receive and understand information related to the study and give written informed consent
- •Patient affiliated to the French social security system
排除标准
- •Patient with contraindications to MRI:
- •pacemaker or automatic defibrillator, pump
- •implanted
- •auditory, anal, painkiller neurostimulator, etc ...
- •ferromagnetic bodies in soft tissues, body
- •intraocular foreigners, cerebrovascular clips
- •claustrophobia
- •Patient presenting, in the judgment of the investigator, an illness that may prevent participation in the procedures provided by the study
- •Patient who has been operated urgently
- •Pregnant or lactating patient
- •Patient in exclusion period (determined by a previous or a current study)
- •Patient under the protection of justice
- •Patient under guardianship or trusteeship
- •Patient subject to a legal protection measure or out of state to express their consent
- •Patient in a situation of social fragility
- •A patient may be excluded at the end of the examination if at least one of the three sequences of bili-MRI could not be obtained (apnea impossible, image reconstruction problem).
结局指标
主要结局
Global quality of the images evaluated with a Likert score
时间窗: 1 day: from the consent signature to the end of the exam
The global Likert score corresponds to the average of scores varying between 1 and 5 and based on the following criteria : i. diagnostic quality (feasibility of establishing a diagnosis when reading the image), including canal visibility (from score 1 = no diagnostic to score 5 = Excellent) ii. the sharpness of the image, especially the canal sharpness (from score 1 = too blurry / illegible to score 5 = sharp) iii. removal of the background signal (contrast quality) (from score 1 = too much background / illegible to score 5 = no background). The global Likert score will vary between 1 (worst) and 5 (best) as well.
次要结局
- Comparison of the global quality of the images evaluated with a Likert score between the three sequences performed with the 1.5T MRI scanner(1 day: from the consent signature to the end of the exam)
- Comparison of the global quality of the images evaluated with a Likert score between the three sequences performed with the 3T MRI scanner(1 day: from the consent signature to the end of the exam)
- Comparison of the sequences between 1.5T and 3T MRI scanners evaluated with the Likert score(1 day: from the consent signature to the end of the exam)
- Performance of each sequence in the visualization of the pathology and / or an anatomical variant in the 1.5T magnetic field group, evaluated in percentage(1 day: from the consent signature to the end of the exam)