Multi-Reader Multi-Case, Cross-Over, Retrospective Study to Evaluate the Effectiveness of CadAI-B Dx for Decision Support in Breast Ultrasound
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 797
- 试验地点
- 1
- 主要终点
- Area Under the Localization Receiver Operating Characteristic (LROC) Curve (AULROC)
研究概览
简要总结
This is a retrospective, fully-crossed, multi-reader, multi-case (MRMC) study to evaluate the effectiveness of 'CadAI-B Dx' (CadAI-B) for decision support in breast ultrasound. The study compares the diagnostic performance of readers interpreting breast ultrasound images with and without the aid of CadAI-B. A total of 797 patient cases will be included, comprising 350 cases with a confirmed diagnosis of malignancy and 447 cases with a confirmed benign diagnosis. Sixteen readers will participate in the study to evaluate the device.
详细描述
The study utilizes a crossover design where all readers independently review all cases. The control arm consists of a reading session where participating readers independently review cases without the assistance of the CadAI-B device (unaided reading). The experimental arm involves reading with CadAI-B assistance (AI-aided reading). To minimize potential bias, a washout period of four weeks will be maintained between the unassisted and assisted reading sessions for each reader. The primary hypothesis is that CadAI-B assistance significantly improves overall reader performance in breast ultrasound interpretation, as measured by the area under the Localization Receiver Operating Characteristic (LROC) curve (AULROC).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 22 years or older at the time of the breast ultrasound examination.
- •Standard B-mode breast ultrasound images available for analysis.
- •Lesions must have a confirmed diagnosis based on one of the following reference standards:
- •Malignant Cases: Diagnosis of breast cancer confirmed through biopsy or surgery.
- •Benign Cases: Confirmed as benign through biopsy or surgical excision, or confirmed as having no evidence of malignancy for at least 2 years of follow-up.
排除标准
- •mages containing modes other than standard B-mode ultrasound, such as Doppler, elastography, or other annotations/overlays.
- •Patients who have breast implant(s).
- •Patients suffering from significant breast trauma or mastitis at the time of the breast ultrasound examination.
- •Images of post-surgical resection sites.
- •Images where multiple lesions are present within a single 2D ultrasound image
结局指标
主要结局
Area Under the Localization Receiver Operating Characteristic (LROC) Curve (AULROC)
时间窗: Through study completion, approximately 2 months
The difference in reader performance between the unaided and AI-aided sessions in breast ultrasound interpretation. LROC reflects both detection accuracy and localization precision. The primary hypothesis is that the mean AULROC of all readers for the AI-aided reading mode is greater than that for the unaided reading mode.
次要结局
- Sensitivity(Through study completion, approximately 2 months)
- Positive Predictive Value (PPV)(Through study completion, approximately 2 months)
- Negative Predictive Value (NPV)(Through study completion, approximately 2 months)
- Inter-reader Agreement(Through study completion, approximately 2 months)
- Reading Time(Through study completion, approximately 2 months)
- AI-Ground Truth Agreement(Through study completion, approximately 2 months)