Evaluation of TaiHao Breast Ultrasound Diagnosis Software
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 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
研究组 & 干预措施
First session: manual review first and then review with CADx
Reader Group X interpret the "Dataset A" cases in different random order without any assistance of AI first, and then interpret the "Dataset B" cases in different random order with TaiHao AI system.
干预措施: Reader Group X - Session 1 (Diagnostic Test)
First session: review with CADx first and then manual review
Reader Group Y interpret the "Dataset A" cases in different random order with TaiHao AI system first, and then interpret the "Dataset B" cases in different random order without any assistance of AI.
干预措施: Reader Group Y - Session 1 (Diagnostic Test)
Second session: manual review first and then review with CADx
At least 4 weeks after first session for memory washing out. Reader Group X interpret the "Dataset A" cases in different random order with TaiHao AI system first, and then interpret the "Dataset B" cases in different random order without any assistance of AI.
干预措施: Reader Group X - Session 2 (Diagnostic Test)
Second session: review with CADx first and then manual review
At least 4 weeks after first session for memory washing out. Rader Group Y interpret the "Dataset A" cases in different random order without any assistance of AI first, and then interpret the "Dataset B" cases in different random order with TaiHao AI system.
干预措施: Reader Group Y - Session 2 (Diagnostic Test)
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)