Breast Density Measurements in Digital Mammography and Breast Tomosynthesis Systems of Different Pixel Size
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Comparison of VolparaTM's Volumetric Breast Density measurements and its 4-classes density rating measured in DBT against QuantraTM 3D and radiologist's BI-RADS manual classification
研究概览
简要总结
Breast cancer (BC) is the most frequently diagnosed cancer in women worldwide. The cause of developing BC is currently unknown. However, there are several risk factors, such as volumetric breast density (VBD), which have been proved to have a relationship with BC. The assessment of breast density is typically performed subjectively using the 4-classes density classification described by American College of Radiology. However, in the last years, automated breast density software tools have been developed (e.g. Volpara, Quantra). In this work, VBD measurements from VolparaTM (v. 1.5.4.0) will be compared between Full-Field Digital Mammography (FFDM) and Digital Breast Tomosynthesis (DBT) of the same pacient ('combo mode'). Images will be acquired in a Hologic Selenia Dimensions, the most common FFDM/DTB system, where image resolution is different for FFDM (70 um) and DBT (140 um).
This study (1) evaluates the consistency between Volpara's breast density measurements and spatial distribution for the two imaging techniques (FFDM and DBT) in a Hologic Selenia Dimensions, and (2) compares VDB measurements with other similar tool (Quantra) and radiologists breast density manual classification.
详细描述
Monocentric, prospective and observational study which will analyse a series of 300 cases (FFDM + DBT) from consecutive women. Image acquisitions will take place within the Área de radiología Mamaria y Ginecológica located at Parc Taulí Hospital Universitari, Sabadell. The purposes of this study will be explained to each potential candidate and if agreed to participate, a consent form will be signed.
Inclusion criteria:
- Subjects over 18 years old.
- Acceptance of participation through a signed consent form.
- Asymptomatic subjects
Exclusion criteria:
- Subjects refusing to participate or sign the consent form.
- Subjects with prior history of breast surgery or biopsy with markers.
- Subjects with breast prostheses.
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
- 40 Years 至 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Acceptance of participation through a signed consent form.
- •Asymptomatic subjects
排除标准
- •Subjects refusing to participate or sign the consent form.
- •Subjects with prior history of breast surgery or biopsy with markers.
- •Subjects with breast prostheses.
- •Subjects with biopsy marker clips
结局指标
主要结局
Comparison of VolparaTM's Volumetric Breast Density measurements and its 4-classes density rating measured in DBT against QuantraTM 3D and radiologist's BI-RADS manual classification
时间窗: 1 year
Consistency of breast density measurements from the latest VolparaTM breast density tool for Hologic's FFDM and DBT images (i.e. combo mode).
时间窗: 1 year
次要结局
未报告次要终点
研究者
Oliver Diaz-Montesdeoca
Visiting researcher
Corporacion Parc Tauli