Breast MRI Spectroscopy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- To determine if spectroscopy of the breast can be performed and can be functional in a clinical environment.
研究概览
简要总结
The purpose of this study is to provide physicians with additional information not available with standard imaging methods for breast disease.
As part of the MRI examination ordered by your physician, a new method of analyzing the images or pictures will be used. This new method is called spectroscopy and is used routinely on other parts of the body such as the prostate and brain. Pictures produced with this sequence may look slightly different than the regular MRI pictures. Using spectroscopy data, it may be possible to distinguish benign conditions of the breast from malignant tumors and provide more precise information than can be obtained with regular MRI.
详细描述
Our aim is to perform MR Spectroscopy (MRS) on 150 evaluable patients at the end of their routine breast MRI examination using a software package from General Electric Medical Systems Milwaukee, WI). This will add time to the routine examination but will not involve additional injections of contrast. We will analyze the spectroscopic data to determine if benign lesions can be reliably differentiated from malignant ones.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Scheduled for diagnostic breast MRI examination or interventional procedure for a known or suspected breast lesion
排除标准
- •Patients who would be normally excluded from undergoing an MRI examination:
- •Patients with a pacemaker, aneurysm clip or any other condition that would warrant avoidance of a strong magnetic field
结局指标
主要结局
To determine if spectroscopy of the breast can be performed and can be functional in a clinical environment.
时间窗: 12 months
次要结局
- To determine if the data obtained can be reliably analyzed and useful to the final interpretation of the breast MRI examination.(12 months)