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临床试验/NCT00594412
NCT00594412已完成不适用

Validation of (1)H-Magnetic Resonance Spectroscopy for Quantification of Hepatic Triglyceride Content

National Institute of Allergy and Infectious Diseases (NIAID)1 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2007年12月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
53
试验地点
1
主要终点
Validate 1H-Magnetic Resonance Spectroscopy to assess hepatic steatosis

研究概览

简要总结

This study will determine whether a magnetic resonance imaging (MRI) test of the liver can accurately measure the amount of fat in the liver compared to the results of a liver biopsy.

People 18 years of age and older who are scheduled to have or who have already had a liver biopsy as part of their medical care within 1 month of enrollment in this study may be eligible to participate.

Participants undergo an MRI. For this procedure, the subject lies still on a table that slides into a narrow metal cylinder (the MRI scanner) for 30 to 60 minutes. A special pad or tube is placed around the abdomen to improve the image of the liver obtained. Earplugs are placed in the ears to muffle loud thumping and knocking sounds that occur with the electrical switching of the magnetic field. The findings of the MRI are compared with those of the liver biopsy.

详细描述

Percutaneous liver biopsy remains the gold standard test to evaluate hepatic fat content, fibrosis and cirrhosis, but there is growing interest in the application of magnetic resonance imaging (MRI) techniques such as (1)H-Magnetic Resonance Spectroscopy ((1)H-MRS) as a non-invasive approach to quantify these characteristics. The ability to accurately quantify hepatic metabolites, such as intrahepatic lipid, has important implications for clinical evaluation and management of patients with liver related diseases and may obviate the need for liver biopsies in a number of clinical settings. The current proposal is designed to develop and validate hepatic (1)H-MRS capabilities at the NIH Clinical Center and to use this technique in a subsequent study to estimate the prevalence of hepatic steatosis among persons living with HIV/AIDS. In the present study we propose to complete MRI with (1)H-MRS in 70 adults who will be undergoing percutaneous liver biopsy in order to establish the ability of (1)H-MRS to accurately assess hepatic fat content compared to histopathological scoring.

研究设计

研究类型
Interventional
分配方式
Non Randomized
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
否

入选标准

  • •INCLUSION CRITERIA:
  • •Age 18+, male or female
  • •Planned liver biopsy or liver biopsy within the past month with pathology samples available to be read at NIH CC

排除标准

  • •Known current pregnancy or pregnancy within 6 months
  • •Contraindications to MRI
  • •Subject is deemed unable to comply with requirements of study participation

结局指标

主要结局

Validate 1H-Magnetic Resonance Spectroscopy to assess hepatic steatosis

次要结局

未报告次要终点

研究者

研究点 (1)

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