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临床试验/NCT06703450
NCT06703450Enrolling By Invitation不适用

Noninvasive Diagnosis of Liver Fibrosis With Gadopiclenol DCE-MRI in Metabolic Dysfunction-associated Steatohepatitis (MASH)

Icahn School of Medicine at Mount Sinai2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年2月28日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
50
试验地点
2
主要终点
Liver Stiffness by MR Elastography

研究概览

简要总结

The goal of this study is to assess the value of liver dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) and texture analysis post gadopiclenol for liver fibrosis staging, in comparison with MR elastography, T1 mapping, ultrasound elastography and blood tests in 50 initial patients with metabolic dysfunction-associated steatohepatitis (MASH).

详细描述

Metabolic dysfunction-associated steatotic liver disease (MASLD, formerly known as nonalcoholic fatty liver disease or NAFLD) is characterized by the accumulation of excess fat in the liver, ranging from mild forms like non-alcoholic fatty liver (NAFL) to more severe stages such as metabolic dysfunction-associated steatohepatitis (MASH, formerly known as nonalcoholic steatohepatitis or NASH) with associated inflammation, ballooning, fibrosis, and cirrhosis. The severity of MASH and increasing fibrosis stages is associated with higher morbidity and mortality rates. The study will compare dynamic contrast-enhanced (DCE)-MRI measurements of perfusion using gadopiclenol for diagnosis of liver fibrosis to MR elastography and transient elastography, T1 mapping, ultrasound elastography and blood tests, using histopathology as the reference in patients with MASH. In this study, the value of DCE-MRI and texture analysis using gadopiclenol, a new macrocyclic, non-ionic, extracellular contrast agent with high relaxivity will also be assessed which provides, at a lower dose, better contrast-to-noise ratio than gadoterate, gadobenate, and gadobutrol.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with suspected MASLD (F0-F4) with clinically indicated percutaneous or transjugular liver biopsy within 6 months of MRI (before or after MRI).
  • Both genders.
  • Age > 18 years.
  • Any racial/ethnic background.

排除标准

  • Previous history or current diagnosis of HCC or decompensation.
  • Contraindications for MRI, including
  • Medically unstable
  • Intracranial clips
  • Metal implants
  • Suspected or confirmed metal in eyes
  • Cardiac pacemaker, implanted defibrillator, other implanted electronic device
  • Pregnancy: Pregnancy tests will be offered to women of childbearing age at no cost
  • Severe claustrophobia

研究组 & 干预措施

Participants with liver disease

Participants with liver disease for diagnosis of liver fibrosis to have DCE-MRI

结局指标

主要结局

Liver Stiffness by MR Elastography

时间窗: during procedure (MRI)

Liver stiffness that is quantitively measured by MR Elastography and correlated with grade of tissue fibrosis from histopathology. Min and Max Scale: 0-20 kilopascals (continuous variable). Higher score indicates poorer health outcomes.

次要结局

  • Total Liver Flow(during procedure (MRI))
  • Arterial Fraction of flow(during procedure (MRI))
  • Portal Venous Fraction of flow(during procedure (MRI))
  • Distribution volume of contrast(during procedure (MRI))

研究者

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

Sara Lewis

Radiology Physician

Icahn School of Medicine at Mount Sinai

研究点 (2)

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