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临床试验/NCT05462093
NCT05462093尚未招募不适用

Clinical Application of Annual Liver Multiscan and MRCP+ in Primary Sclerosing Cholangitis: the CATCH-IT Study

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)0 个研究点目标入组 200 人开始时间: 2022年7月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
200
主要终点
Delta of cT1 in patients with PSC during follow-up

研究概览

简要总结

Primary sclerosing cholangitis (PSC) is a chronic progressive biliary disease that affects approximately 1200 patients in the Netherlands and around 80,000 in the Western world. It is often accompanied by ulcerative colitis (UC) or Crohn's disease affecting the large bowel. The cause of PSC is unknown, there is no medical therapy available that has proven to halt disease progression and the median time until death or liver transplantation is 13-21 years.

Diagnosis is made by magnetic resonance cholangiography (MRC), or in the case of so called small duct disease by liver biopsy.

Due to the heterogeneous disease course and the relatively low clinical event rate of 5% per year it is difficult to predict prognosis of individual patients or to recommend any surveillance strategy for malignancies. Also, the lack of surrogate endpoints impedes performing clinical research. Recently, two new post-processing tools have been developed to characterize and quantify abnormalities in the biliary tree as well as excretory function captured by MRC. These tools called MRCP+ (quantitative magnetic resonance cholangiopancreatography +) and LiverMultiscan (LMS) hold the prospect of adequately depicting and quantifying lesions of the biliary tree as well as capturing functional derailment. However, several features must be tested before the utility of this tools in clinical patient care can be concluded. Therefore, the aim of this study is to investigate the utility of these novel techniques in monitoring disease activity by performing consecutive annual MRI's.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

入选标准

  • Established PSC diagnosis according to the IPSCSG definitions
  • Able to give informed consent

排除标准

  • Known allergy for MRI contrast agents, implants non-compatible with MRI or extreme claustrophobia causing discontinuation of MRI studies.

结局指标

主要结局

Delta of cT1 in patients with PSC during follow-up

时间窗: 1st MRI = baseline = week 0; 2nd MRI = year 1 = week 52; 3rd MRI = year 2 = week 104; 4th MRI = year 3 = week 156; 5th MRI = year 4 = week 208; 6th MRI = year 5 = week 260.

The delta of cT1 (in ms), measured by LiverMultiscan, which will be assessed by performing paired t-tests.

次要结局

  • Variance in unstable patients(1st MRI = baseline = week 0; 2nd MRI = year 1 = week 52; 3rd MRI = year 2 = week 104; 4th MRI = year 3 = week 156; 5th MRI = year 4 = week 208; 6th MRI = year 5 = week 260.)
  • Correlation of cT1 and MRCP+ metrics with fibroscan and MELD(1st MRI = baseline = week 0; 2nd MRI = year 1 = week 52; 3rd MRI = year 2 = week 104; 4th MRI = year 3 = week 156; 5th MRI = year 4 = week 208; 6th MRI = year 5 = week 260.)
  • Assesment of th mean, median and range of cT1 and MRCP+ metrics in stable PSC patients(1st MRI = baseline = week 0; 2nd MRI = year 1 = week 52;)
  • Difference in cT1 in patients with or without endoscopic intervention(1st MRI = baseline = week 0; 2nd MRI = year 1 = week 52; 3rd MRI = year 2 = week 104; 4th MRI = year 3 = week 156; 5th MRI = year 4 = week 208; 6th MRI = year 5 = week 260.)
  • Correlation of cT1 and MRCP+ metrics and development of dominant strictures(1st MRI = baseline = week 0; 2nd MRI = year 1 = week 52; 3rd MRI = year 2 = week 104; 4th MRI = year 3 = week 156; 5th MRI = year 4 = week 208; 6th MRI = year 5 = week 260.)
  • Variance of the delta of cT1 and MRCP+ metrics in stable patients(1st MRI = baseline = week 0; 2nd MRI = year 1 = week 52; 3rd MRI = year 2 = week 104; 4th MRI = year 3 = week 156; 5th MRI = year 4 = week 208; 6th MRI = year 5 = week 260.)
  • Correlation of cT1 and MRCP+ metrics and incidence of CCA(1st MRI = baseline = week 0; 2nd MRI = year 1 = week 52; 3rd MRI = year 2 = week 104; 4th MRI = year 3 = week 156; 5th MRI = year 4 = week 208; 6th MRI = year 5 = week 260.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

C.Y. Ponsioen

Principal Investigator

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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