跳至主要内容
临床试验/NCT03809559
NCT03809559已完成不适用

Repeatability and Reproducibility of Quantitative MRCP

Perspectum2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年7月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Perspectum
入组人数
40
试验地点
2
主要终点
Assessment of Repeatability and Reproducibility of Quantitative MRCP

研究概览

简要总结

This study aims to determine the repeatability and reproducibility of Quantitative Magnetic Resonance Cholangiopancreatography (MRCP).

Imaging scientists at Perspectum Diagnostics have developed a hessian-based mathematical model to enhance conventional MRCP to a 3D geometric model of the biliary tree, 'Quantitative MRCP'. This enables advanced quantitative measurement of bile duct width, orientation, branching point and curvative metrics.

The technology has been validated against 3D printed phantoms for accuracy, and early clinical research has demonstrated the technology has potential for clinical impact, with improvement in radiologist performance versus conventional non-enhanced MRCP imaging (Vikal et al 2017).

Quantitative MRCP aims to act as a tool to not only improve assessment of the current status of the biliary tree, but also act as a mechanism to track change within the ducts. Thus, it must be established that any change between scans is due to change in the physiology of the individual and not due to a quirk or fault of the technology.

In order to achieve this a series of scans will be performed on an individual over a short period of time, for which the condition of the biliary tree within that individual can be assumed to be constant. Between each scan, subject and coil repositioning will occur.

The study will recruit a group of adult volunteers, from both diseased groups and healthy groups in order to achieve a range of physiological biliary metrics.

详细描述

Biliary-related conditions, such as autoimmune conditions Primary Biliary Cholangitis (PBC), and Primary Sclerosing Cholangitis (PSC), and also cancers such as cholangiocarcinoma, affect tens of thousands of individuals in the UK each year. All biliary conditions require careful tracking of the structure and integrity of the biliary tree so that intervention can be carefully planned and with that, outcomes improved.

The current non-invasive gold-standard for assessment of the biliary tree is MRI-based Magnetic Resonance Cholangiopancreatography (MRCP). This method uses no contrast and takes up to 10 minutes to obtain within a normal scan event. However, there are several limitations to its use which include, images having great variability in quality and are used mainly for qualitative analysis. Using conventional MRCP a consultant can, depending on image quality; identify key structures, inform diagnosis, and give a general assessment on the health of the biliary tree structure. However, current MRCP imaging only allows limited quantitative assessment of the ducts. More extensive, objective quantification has the potential to dramatically improve the usability of MRCP imaging.With this in mind, imaging scientists at Perspectum Diagnostics have developed a hessian-based mathematical model to enhance conventional MRCP to a 3D geometric model of the biliary tree, 'Quantitative MRCP'. This enables quantitative measurement of bile duct width, orientation, branching point and curvative metrics.

The technology has been validated against 3D printed phantoms for accuracy, and early clinical research has demonstrated the technology has potential for clinical impact, with improvement in radiologist performance versus conventional non-enhanced MRCP imaging (Vikal et al 2017). Thus, further research into the technology and its viability as an enhancement to current procedure is necessary if it is to replace conventional MRCP as the primary method of non-invasive biliary assessment.

Integral to the development of any new technology, is demonstration of the repeatability and reproducibility of the method. This is the inter-examination variability in results. Quantitative MRCP aims to act as a tool to not only improve assessment of the current status of the biliary tree, but also act as a mechanism to track change within the ducts. Thus, it must be established that any change between scans is due to change in the physiology of the individual and not due to a quirk or fault of the technology.

The above will be tested by a series of scans performed on an individual over a short period of time, for which the condition of the biliary tree within that individual can be assumed to be constant. Between each scan, subject and coil repositioning will occur. The study will recruit a group of adult volunteers, from both diseased groups and healthy groups in order to achieve a range of physiological biliary metrics.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Persons over the age of 18 years
  • •Participant is willing and able to give informed consent for participation in the study.
  • •EITHER: Participant has a medical history of a liver or biliary tree related condition OR: Person is a healthy volunteer.

排除标准

  • •The participant may not enter the study if they have any contraindication to magnetic resonance imaging (inc pregnancy, extensive tattoos, pacemaker, shrapnel injury, severe claustrophobia).
  • •The participant may not enter the study if they have an allergy to pineapple juice.
  • •Any other cause, including a significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or may influence the participant's ability to participate in the study

结局指标

主要结局

Assessment of Repeatability and Reproducibility of Quantitative MRCP

时间窗: 6 months

Assessment of the variability of bile duct volume, bile duct diameter, branching points and locations of regions of variation in bile duct widths and percentages, as measured by quantitative MRCP between: A. Repeated scans of the same participant acquired under the same conditions B. Repeated scans of the same participant acquired on scanners which differ by field strength and/or manufacturer

次要结局

  • Comparison of conventional MRCP and quantitative MRCP(6 months)
  • Intra and Inter-operator reproducibility(6 months)

研究者

发起方
Perspectum
申办方类型
Industry
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

Repeatability and Reproducibility of Quantitative... | 临床试验