Digital Breast Tomosynthesis Versus Digital Mammography: A National Multicenter Trial
Digital Breast Tomosynthesis vs. Digital Mammography: A National Multicenter Trial
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.
研究概览
地位
条件
详细说明
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.
The purpose of this study is to evaluate the novel technique of DBT compared to routine FFDM in a clinical large sample study (600 participants) to provide the path to implementation of this new technique into clinical and screening routine.
研究类型
注册 (预期的)
联系人和位置
学习地点
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Vienna、奥地利、A-1090
- 招聘中
- Medical University of Vienna
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接触:
- Thomas Moritz, MD
- 电话号码:4818 +43140400
- 邮箱:thomas.moritz@meduniwien.ac.at
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Vienna、奥地利、A-1100
- 招聘中
- Kaiser Franz Josef Spital
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接触:
- Gabrielle Kienzer, MD
- 电话号码:3608 +43160191
- 邮箱:Gabrielle.kienzer@wienkav.at
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Vienna、奥地利、A-1140
- 招聘中
- Hanusch Krankenhaus
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接触:
- Reinhard Bernt, MD
- 电话号码:86630 +43191021
- 邮箱:reinhard.bernt@wgkk.at
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Styria
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Graz、Styria、奥地利、A-8036
- 招聘中
- Medical University of Graz
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接触:
- Sabine Oswald, MD
- 电话号码:13850 +43 316385
- 邮箱:sabine.oswald@klinikum-graz.at
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Upper Austria
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Wels、Upper Austria、奥地利、A-4600
- 招聘中
- Klinikum Wels-Grieskirchen
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接触:
- Stefan Meindl, MD
- 电话号码:2413 +437242415
- 邮箱:stefan.meindl@klinikum-wegr.at
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
The study population consists of two groups:
One screening group consisting of asymptomatic women (Age 40+) referred for a screening mammography examination.
The second group consists of women aged 25+ referred for further examination of a breast lesion.
描述
Inclusion Criteria:
- 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)
Exclusion Criteria:
- Pregnant and breast feeding women
- Unable to tolerate breast compression
- Breast implants
- Unable to understand or execute written informed consent
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
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Breast Cancer Screening Patients
Group 1 consists of Women referred to Breast Cancer Screening examinations at a participating Austrian Breast Imaging Site
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Diagnostic Patients
Patients referred to a participating Breast Imaging Center for a clinically or radiologically detected breast lesion
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Specificity of Digital Breast Tomosynthesis in the characterization of Breast lesions
大体时间:One year
|
One year
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次要结果测量
结果测量 |
大体时间 |
---|---|
Sensitivity of Digital Breast Tomosynthesis in the detection of malignant breast lesions
大体时间:One year
|
One year
|
合作者和调查者
调查人员
- 首席研究员:Thomas Moritz, MD、Medical University of Vienna
- 研究主任:Thomas Helbich, MD Prof. MBA MSc、Medical University of Vienna
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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