跳至主要内容
临床试验/NCT00543777
NCT00543777已完成1 期

Validation Study of Magnetic Resonance Elastography and 2-Point Dixon MR Imaging Techniques in Diffuse Liver Disease

M.D. Anderson Cancer Center2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2007年9月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
44
试验地点
2
主要终点
Overall Image Quality of Magnetic Resonance Elastography (MRE)

研究概览

简要总结

The goal of this clinical research study is to test the accuracy of magnetic resonance elastogram (MRE) and 2-point dixon magnetic resonance imaging (2PD MRI) using new computer software (called "phase correction algorithm") in patients who might have liver disease.

详细描述

Finding liver damage as early as possible is important. Traditionally, biopsies have been used for this purpose. Biopsies are accurate but can only check a small part of the liver. Tissue fat and liver stiffness are common in patients with liver disease.This study is testing new MRI techniques (called an MRE) that may be able to test for these symptoms on the entire liver, in a short time.

A typical MRI uses a large magnet instead of x-rays to take pictures of the inside of your body. The MRE will be done on a standard MRI scanner.

Study Visit:

The MRE procedure is useful for identifying tissue stiffness. For the MRE procedure, you will lie on your back on the examination table, and a pneumatic driver (a light-weight, clear plastic drum, about 10 inches wide and 1 inch thick) will be placed over the upper abdomen. You will feel a vibration (like a cell phone or beeper vibrating). This vibration will create very small waves in the body. The scanner will then receive the vibrations from the liver and use them to create images of the liver tissue. The MRE will take about 40 seconds. The driver will only be turned on during this time.

Once the MRE is completed, you will then have a 2PD MRI scan while you are still lying on the table. This procedure is useful in identifying fat tissue. This will take about 20-60 seconds. The total exam time will be no more than 20 minutes, including the preparation time.

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

性别
All
接受健康志愿者

入选标准

  • Non-oncologic patients from VAMC in Houston:
  • Biopsy proven or clinically suspected advanced parenchymal liver disease
  • Core biopsies obtained within 1-month of MRI/MRE
  • No treatment affecting the status of liver between MRI/MRE and post-imaging biopsy
  • Signed consent
  • Oncologic patients at MDACC:
  • Clinically or radiographically suspected liver damage, hepatic steatosis, hepatitis, hepatic fibrosis or cirrhosis
  • Surgical or core biopsy scheduled within 4 weeks of MRI/MRE
  • Signed consent

排除标准

  • Claustrophobia
  • Contraindications for MRI
  • Unable to hold a breath
  • Ascites or other clinical or radiographical signs of portal hypertension

结局指标

主要结局

Overall Image Quality of Magnetic Resonance Elastography (MRE)

时间窗: 2 Years

次要结局

  • Association Between Degrees of Stiffness Measured by MRE in kPa and Histopathological Grades of Fibrosis and Steatohepatitis(Baseline to end of trial, up to 2 years)
  • Hepatic Steatosis(Baseline to the end of the trial, up to 2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验