System-integrated Point-of-Care Ultrasound in Breast Cancer Screening
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Region Skane
- 入组人数
- 4,800
- 试验地点
- 2
- 主要终点
- Sensitivity
研究概览
简要总结
To assess the feasibility, safety, and clinical performance of community-based breast cancer screening incorporating clinical breast exam and short-termed trained examiners performing AI-supported breast POCUS for triage in limited-resource settings.
详细描述
Following awareness campaign, asymptomatic and symptomatic women are invited to breast cancer screening. The screening intervention consists initially of clinical breast exam (CBE). Those that are positive at CBE or that present with symptoms are further examined with targeted artificial intelligence (AI)-supported breast point-of-care ultrasound (POCUS) on the complaint site. The AI-supported POCUS is performed by clinical nurses or clinical officers that have undergone a short training program and certification process in POCUS examination. In the first stage of the study, the same women will also be examined by an expert on site (breast radiologist). If clinical safety can be determined, the second stage of the study will start in which expert radiologist will not be on site. Ultrasound images will be assessed by breast radiologists that will serve as reference standard (on site in stage 1 and remotely in stage 2). Women positive at POCUS triage (positive ultrasound finding or with predefined alarming clinical symptoms) will be referred to further follow up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
盲法说明
The result of AI-supported POCUS performed by nurse/clinical officer will be masked for the expert radiologist in the first stage of the study
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Asymptomatic women from the age of 30 with no upper age limit
- •Symptomatic women 18 years or older.
排除标准
- •Individuals unable to comprehend the study information due to language barriers or cognitive impairments.
研究组 & 干预措施
CBE follow by targeted AI-supported POCUS
In the first stage, an expert breast radiologist will be involved on site and in the second stage, remotely.
干预措施: AI (Diagnostic Test)
结局指标
主要结局
Sensitivity
时间窗: Estimated 2 months (from enrollment until sufficient number of positive participants according to expert assessment)
The primary endpoint is sensitivity, defined as the proportion of diseased women correctly classified as positive by non-experts using AI-supported POCUS. Expert breast radiologists will be used as reference standard
次要结局
- Specificity(2 months)
- Positive Predictive Value(2 months)
- Negative Predictive Value(2 months)
- Cancer Detection Rate(2 months)
- Recall Rate(2 months)
- False Positive Rate(2 months)
- Optimal threshold analysis(2 months)
- Cancer characterstics(6 months)
- Breast cancer in stage I-II(12 months)
- WHO Global Breast Cancer Initiative key performance indicators(12 months)
- Receiver Operating Characteristic and Area Under the Curve(2 months)
- Usability and Acceptability(2 months)