A Retrospective, Observational, Case-Controlled, Multi-Reader, Multi-Case, Receiver Operating Characteristic (ROC) Study of Reader Performance When SoftVue Automated Breast Ultrasound (SV) and Digital Screening Mammography (DM) Are Combined, Compared to Screening Mammography Alone, in Asymptomatic Women With Heterogeneous or Extremely Dense Breast Parenchyma.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- MRMC Analysis: ROC AUC
研究概览
简要总结
The purpose of this multi-reader, multi-case (MRMC) reader study is to evaluate reader performance when SoftVue™ automated breast ultrasound and screening mammography are combined, compared to screening mammography alone, in women with dense breast parenchyma. This includes obtaining information that can be used to properly plan, design, and power future ROC reader studies.
This reader study will include a minimum of 6 radiologist readers and an enriched sample of at least 100 breast screening or diagnostic cases to be selected from the library of images collected under Delphinus Protocol #DMT-2015.001 (NCT03257839). The reader study image case set will be enriched with cancer cases.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hold a current United States medical license
- •Be American Board of Radiology Certified
- •Be MQSA-qualified
- •Be experienced in reading FFDM images on a monitor (softcopy)
- •Be experienced in reading Breast Ultrasound images on a monitor (softcopy)
- •Have completed a Financial Disclosure showing no Conflicts of Interest
- •Have provided a current curriculum vitae (CV)
- •Have provided a signed Readers' Agreement
- •Have provided written Informed Consent
- •All qualified and confirmed readers will complete a multi-module SoftVue™ training program prior to their participation in a reading session for this study.
排除标准
- 未提供
结局指标
主要结局
MRMC Analysis: ROC AUC
时间窗: 8 Weeks
Area under the ROC curve (AUC)
次要结局
- Sensitivity and Specificity(8 Weeks)