NCT04551105已完成不适用
Evaluation of TaiHao Breast Ultrasound Diagnosis Software
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Comparing the Area Under the LROC Curve
研究概览
简要总结
The BR-USCAD DS Module is a computer-assisted detection and diagnosis software based on a deep learning algorithm. This retrospective, fully-crossed, multi-reader, multi-case (MRMC) study aims to compare the performances of readers without and with the aid of the Breast Ultrasound Image Reviewed with Assistance of Computer-Assisted Detection and Diagnosis System (BR-USCAD DS) in interpreting breast ultrasound images of lesions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •B-mode breast ultrasound image
- •Female, age 21 or older
- •Breast lesion images acquired before a biopsy or surgery - these images were retrospectively collected with histology report.
- •Non-biopsied benign lesions with negative follow-up for a minimum of 24 months
- •At least two orthogonal views of a lesion
排除标准
- •Breast lesion images acquired after biopsy or surgery.
- •Any breast surgeries or interventional procedures in the 12 months prior to ultrasound imaging
- •Case demonstrating administrative or technical errors
- •Multiple lesions in one 2-D ultrasound image
- •Breast ultrasound images with Doppler, elastography, or other overlays present
- •Case with less than 2-year follow-up and without biopsy confirmation
结局指标
主要结局
Comparing the Area Under the LROC Curve
时间窗: 10 weeks
The area under the LROC curve (AUC_LROC) on the diagnosis of benign and malignant lesions was computed and compared for Aim 1 (baseline) and Arm 2 (with BU-CAD assistance) studies.
次要结局
- The Sensitivity, Specificity, PPV, and NPV Were Computed and Compared for Aim 1 (Baseline) and Arm 2 (With BU-CAD Assistance) Studies.(10 weeks)
- The Reading Time Was Computed and Compared for Aim 1 (Baseline) and Arm 2 (With BU-CAD Assistance) Studies.(10 weeks)
研究者
研究点 (2)
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