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临床试验/NCT01229826
NCT01229826已完成不适用

Magnetic Resonance Elastography (MRE) of Uterine Fibroids

Mayo Clinic1 个研究点 分布在 1 个国家目标入组 134 人开始时间: 2010年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Mayo Clinic
入组人数
134
试验地点
1
主要终点
Acquisition of MR elastography images for comparison.

研究概览

简要总结

The purpose of this study is to gain additional information regarding use of Magnetic Resonance Elastography (MRE) for uterine fibroid characterization. In this study, the investigators will use a new noninvasive technology, MRE, to further characterize the elastic properties of the uterine fibroids. To date, very little is known concerning how the tissue composition of the uterine fibroid may affect its treatment with Magnetic Resonance Guided Focused Ultrasound (MRgFUS).

In this study, the investigators will use a new noninvasive technology, magnetic resonance elastography (MRE), to further characterize the elastic properties of the uterine fibroids. This information will be gathered during routine magnetic resonance imaging for symptomatic uterine fibroids. It is known that some fibroids with increased T2-signal on Magnetic Resonance Imaging(MRI) can be more difficult to treat.

This information will be gathered during routine magnetic resonance imaging for symptomatic uterine fibroids.

详细描述

This is a single-site, non-randomized pilot study to determine whether Magnetic Resonance Elastography (MRE) can be optimized for clinical use as part of the patients routine clinical imaging and to correlate with MR signal characteristics of the uterine fibroid.

MRE is performed at the end of the examination after the standard Magnetic Resonance Imaging protocol.

Aims:

Specific Aim 1: To acquire magnetic resonance elastography images on women who have a clinically ordered pelvic magnetic resonance imaging (MRI) for uterine fibroids.

Specific Aim 2: To examine the correlation between MRE stiffness values and MR T2 signal characteristics for uterine fibroids. For a subset of patients going on to surgery correlation with pathology can also be performed.

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 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women able to give informed consent
  • Women having uterine imaging

排除标准

  • Women currently pregnant
  • Allergy to either gadolinium or iodinated contrast
  • Severe claustrophobia
  • Weight in excess of 250 pounds

结局指标

主要结局

Acquisition of MR elastography images for comparison.

时间窗: every six months

MRE is performed at the end of the examination after the standard Magnetic Resonance Imaging(MRI) protocol.

次要结局

  • Examination of Magnetic Resonance Elastography stiffness values and MR T2.(every six months)

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

David A. Woodrum

David A. Woodrum, M.D., PhD.

Mayo Clinic

研究点 (1)

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