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临床试验/NCT01524029
NCT01524029Unknown不适用

Digital Breast Tomosynthesis vs. Digital Mammography: A National Multicenter Trial

Medical University of Vienna5 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2012年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
600
试验地点
5
主要终点
Specificity of Digital Breast Tomosynthesis in the characterization of Breast lesions

研究概览

简要总结

The goal of this study is to determine the value of the new mammography technique called Digital Breast Tomosynthesis (DBT) compared to the current standard technique Digital Mammography for the early detection of Breast Cancer.

DBT is able to compute a three-dimensional image of a breast from several low-dose mammographies taken from different angles while the device is moving around the breast in a circular motion. This should overcome a significant limitation of Digital Mammography arising from the masking of breast cancer in a mammography image caused by overlying normal breast tissue.

This is a study conducted in several Austrian Breast Imaging Centers.

详细描述

This prospective national multicenter multivendor trial aims at determining the impact of the novel technique Digital Breast Tomosynthesis (DBT) in the assessment and screening for breast cancer. Mammography is the primary imaging modality for the early detection of clinically occult breast cancer.

Despite advances in mammographic technique, mammography is still limited with regard to both sensitivity and specificity. In the majority of cases these limitations arise from the masking of subtle breast cancer lesions by overlapping breast tissue.

DBT is a novel technique that tries to overcome these limitations by performing a 3D-reconstruction of breast tissue from multiple low-dose digital mammographic images acquired in several planes in a 15 to 50 degree angle.

Early studies indicate an advantage of DBT compared to the standard Full Field Digital Mammography (FFDM) in terms of an improvement of specificity without cutback in sensitivity.

Controversy continues over the use of DBT in combination with FFDM or as a standalone screening method without concomitant 2D imaging. Unfortunately, the peer-reviewed publications evaluating DBT are limited and consist of single institution studies with a small number of participants.

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

入选标准

  • Age > 25 years (40 years or older for Screening Cohort)
  • No history of breast cancer
  • Written informed consent
  • Asymptomatic women in follow up for early detection of breast cancer or
  • Patients with a recent positive mammography (BI-RADS 3-5)

排除标准

  • Pregnant and breast feeding women
  • Unable to tolerate breast compression
  • Breast implants
  • Unable to understand or execute written informed consent

结局指标

主要结局

Specificity of Digital Breast Tomosynthesis in the characterization of Breast lesions

时间窗: One year

次要结局

  • Sensitivity of Digital Breast Tomosynthesis in the detection of malignant breast lesions(One year)

研究者

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

Thomas Moritz

Assistenzarzt

Medical University of Vienna

研究点 (5)

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