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临床试验/NCT02812589
NCT02812589已完成不适用

Improving the Specificity of Breast MRI Through Diffusion Tensor Breast MRI (DTI)

University Health Network, Toronto2 个研究点 分布在 1 个国家目标入组 267 人开始时间: 2016年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
267
试验地点
2
主要终点
Validate DTI as a valuable adjunct to improve lesion characterization on breast MRI by using the difference in recall rates

研究概览

简要总结

The breast MRI is used in the preoperative scenario to evaluate the extension of a newly diagnosed breast cancer and to screen the contralateral breast. The scan consists of a series of images taken after the use of intravascular contrast media that may detect areas of enhancement that look malignant, but are actually benign tissue, producing a false positive result. The investigators aim to evaluate a novel MRI sequence of images that does not use contrast, diffusion tensor imaging (DTI). Addition of DTI sequence does not add significantly to the time of standard breast MRI exam. This novel technique provides improved detection of tissue microstructure and is able to differentiate malignant from benign tumor. Hence, the investigators hypothesize that DTI may decrease the false positive rate when compared with standard dynamic contrast-enhanced (DCE) MRI.

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
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Female of any race, ethnicity and lifetime risk.
  • Eighteen years or older.
  • Known recent diagnosis of a breast cancer and normal clinical breast exam of the contralateral side.
  • Self-detected lump suspicious for breast cancer that it has not been biopsied yet.

排除标准

  • Inability to understand the consent form
  • Pregnant or nursing
  • Currently taking tamoxifen, evista (raloxifene), or an aromatase inhibitor for adjuvant therapy or chemoprevention
  • Physically unable to lie down on her belly for at least 10 minutes.
  • Have had benign needle biopsy of the breast performed within 3 months, or breast surgery within 1 year prior to MRI exam.

结局指标

主要结局

Validate DTI as a valuable adjunct to improve lesion characterization on breast MRI by using the difference in recall rates

时间窗: 3 years

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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