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临床试验/NCT03870659
NCT03870659已完成不适用

Value of Abbreviated Breast MRI in Cancer Detection

Assiut University1 个研究点 分布在 1 个国家目标入组 302 人开始时间: 2019年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
302
试验地点
1
主要终点
To evaluate accuracy of abbreviated breast MRI in cancer detection

研究概览

简要总结

Breast cancer is one of the leading causes of death among women, with early detection being the key to improve prognosis and survival.

Randomized controlled trials have found that screening mammography has decreased the mortality of breast cancer by 30%.

However, with a sensitivity of 70%, mammography has its limitations particularly in women with dense breasts.

The use of breast MRI for screening has increased over the past decade. Most experiences exist in women at elevated familial risk of breast cancer. In these women, MRI screening shifts the stage distribution of breast cancers toward lower stages and reduces the fraction of interval cancers.

Kuhl et al in 2014 were the first to report on the feasibility of an abbreviated breast MRI protocol for breast cancer screening. Their protocol consisting of an unenhanced T1-weighted and first contrast-enhanced T1-weighted sequence, subtraction imaging, and a single MIP image.

This groundbreaking study found that image acquisition and interpretation time could be reduced without having a negative impact on diagnostic accuracy.

详细描述

Breast MRI screening is associated with high direct and indirect costs. These, together with the lack of sites that offer high-level breast MRI, limit clinical access to screening MRIs.

One reason for the high cost is that current breast MRI protocols are time consuming to acquire and read. A typical MRI study occupies the MRI system for up to 40 minutes and generates several hundred images.

DCE-MRI allows the assessment of high-resolution breast morphology and enhancement kinetics to depict angiogenesis as a tumor-specific feature. At any given field strength, DCE-MRI is the most sensitive modality for breast cancer detection, with a pooled sensitivity of 93%; DCE-MRI has good pooled specificity of 71%.

With the abbreviated MRI protocol, the acquisition time was substantially decreased to 3 minutes, compared with 17 minutes for the full diagnostic protocol. The interpretation time of the abbreviated protocol was 28 seconds on average and 2.8 seconds when the MIP image alone was evaluated.

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Cross Sectional

入排标准

性别
Female
接受健康志愿者

入选标准

  • All women referred to our radiology department at assiut university hospital for performing breast MRI
  • Exclusion Crieria:
  • no exclusion criteria

排除标准

  • 未提供

结局指标

主要结局

To evaluate accuracy of abbreviated breast MRI in cancer detection

时间窗: 2 years

Sensitivity and specificity of abbreviated breast MRI in detection of cancer will be calculated and compared to those of the full protocol

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

AShassan

Principle investigator

Assiut University

研究点 (1)

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