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临床试验/NCT02061163
NCT02061163撤回1 期

Evaluation of Contrast-Enhanced Ultrasound in Human Crohn's Disease

University of Michigan1 个研究点 分布在 1 个国家开始时间: 2015年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
撤回
试验地点
1
主要终点
Evaluation of bowel wall inflammation and fibrosis in patients with Crohn's disease using CEUS

研究概览

简要总结

To determine if contrast enhanced ultrasound (CEUS) and shear wave elastography can accurately diagnose bowel wall inflammation and fibrosis in patients with known Crohn's disease.

详细描述

Crohn's disease (CD) is an inflammatory condition that affects the intestinal tract (large and small bowels). Some patients with CD may get swelling of the intestinal tract (inflammation) or scarring of the intestinal tract (fibrosis). Fibrosis develops because of chronic injury. Both inflammation (swelling) and fibrosis (scarring) can cause the bowel to narrow, which can lead to the bowel becoming blocked. The long-term goal of this project is to develop new noninvasive radiology imaging tests that can show the difference between bowel wall inflammation and fibrosis. Currently there are no imaging tests that can do this reliably.

Current imaging methods (CT and MRI) that are ordered to help diagnose and follow-up CD are excellent at showing inflammation, but are not accurate for finding fibrosis. CT also exposes patients to small amounts of radiation, and both CT and MRI are costly. We are therefore studying ultrasound imaging, as it is more cost-effective and does not expose patients to radiation. CEUS uses microbubbles in a solution that are injected into a vein in one of the arms. This allows doctors to see the blood flow to parts of the body. This microbubble contrast agent (dye) is called Optison. Another imaging method, called shear wave elastography, uses sound waves to noninvasively measure the stiffness of structures in the body.

It is important to be able to tell the difference between inflammation and fibrosis in Crohn's disease, because narrowing of the bowel due to inflammation generally responds well to medications, whereas narrowing caused by fibrosis does not respond well to medications and may require surgery.

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
10 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients 10 years of age and older
  • Have been diagnosed with small bowel Crohn's disease
  • Are receiving medical therapy for Crohn's disease
  • Are scheduled for surgery (bowel resection) OR
  • Are scheduled for a clinically-indicated MR enterography (MRE)/MRI exam.

排除标准

  • Patients under the age of 10
  • Are pregnant or breast feeding
  • Are significantly overweight - BMI >35-40
  • Have an inability to understand the consent
  • Have prior allergic-like reaction or other adverse reaction to microbubble contrast agent
  • Hypersensitivity to perflutren, blood, blood products or albumen
  • Have a cardiac shunt
  • Known unstable cardiac condition such as history of a heart attach, irregular heartbeat, congestive heart failure, etc.
  • Known acute or chronic kidney disease, moderate/severe lung disease or acute or chronic liver disease

研究组 & 干预措施

Subjects with Crohn's disease

Experimental

Contrast Enhanced Ultrasound Optison

干预措施: Contrast Enhanced Ultrasound (Device)

Subjects with Crohn's disease

Experimental

Contrast Enhanced Ultrasound Optison

干预措施: Optison (Drug)

结局指标

主要结局

Evaluation of bowel wall inflammation and fibrosis in patients with Crohn's disease using CEUS

时间窗: 2 years

CEUS will be performed to evaluate inflammation and fibrosis in patients with Crohn's disease

次要结局

未报告次要终点

研究者

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

Jonathan R. Dillman M.D.

Assistant Professor of Radiology

University of Michigan

研究点 (1)

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