AI-Assisted Opportunistic Breast Cancer Screening Using Non-contrast Chest CT in Women Undergoing Health Examination: A Retrospective Validation and Prospective Single-Arm Interventional Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30,000
- 主要终点
- Incremental Breast Cancer Detection Rate of CT-AI
研究概览
简要总结
This study evaluates the clinical utility of a locked chest CT artificial intelligence model for opportunistic breast cancer screening among women undergoing health examinations. The study includes a retrospective validation phase and a prospective single-arm implementation phase. AI analyzes existing non-contrast chest CT images without additional CT examinations. Clinical physicians make further evaluation decisions based on AI outputs, imaging findings, ultrasound results and clinical information.
详细描述
Retrospective phase: Historical health examination data will be used for offline validation of the locked CT-AI model.
Prospective phase: Eligible women undergoing routine health examination will be consecutively enrolled. Participants receive routine chest CT and breast ultrasound. After routine reports are completed and locked, AI analysis is performed. Cases exceeding predefined thresholds are reviewed by clinicians who determine recall decisions. The study evaluates incremental detection value, recall workflow, safety and feasibility.
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
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female participants aged 18 to 80 years.
- •Undergoing routine health examination.
- •For the prospective phase, no clear ongoing breast-related symptoms at baseline.
- •Availability of complete non-contrast chest CT images. In the prospective phase, chest CT must have been scheduled as part of the routine health examination or for another established clinical purpose and must not be performed solely for this study.
- •Availability of a contemporaneous routine breast ultrasound report and relevant clinical information.
- •Chest CT image quality adequate for AI analysis.
- •Availability of an appropriate follow-up pathway through hospital records, pathology systems, cancer registry data, or approved follow-up methods.
- •For the prospective phase, study information has been provided through an ethics-approved process and the participant has not actively opted out.
排除标准
- •Previous diagnosis of breast cancer, prior treatment for breast malignancy, or breast malignancy already confirmed before baseline.
- •Pregnancy or breastfeeding.
- •Incomplete breast coverage on chest CT, severe image artifacts, missing images, or other conditions that prevent valid AI analysis.
- •Critical baseline or outcome data are substantially incomplete and cannot reasonably be recovered.
- •No effective follow-up pathway can be established.
- •For the prospective phase, the participant actively opts out before AI analysis or explicitly declines use of imaging and clinical data for this study.
研究组 & 干预措施
AI-Assisted Screening Group
Participants undergo routine health examination, including breast ultrasound and non-contrast chest CT when clinically scheduled. No additional chest CT is performed for study purposes. After routine breast ultrasound and chest CT reports are completed and locked, a fixed CT-AI model analyzes the existing chest CT images. Participants meeting predefined AI criteria are reviewed by trained physicians, who make the final decision regarding whether additional breast evaluation is recommended. Further imaging, biopsy, or treatment is determined according to routine clinical practice and participant preference.
干预措施: CT-AI-assisted breast cancer screening (Device)
结局指标
主要结局
Incremental Breast Cancer Detection Rate of CT-AI
时间窗: Within 3 months after the index health examination
Sensitivity of CT-AI for Breast Cancer Detection in the Retrospective Cohort
时间窗: Up to 12 months of retrospective outcome ascertainment
Overall Breast Cancer Detection Rate of Combined CT-AI and Breast Ultrasound Screening
时间窗: Within 3 months after the index health examination
次要结局
- Specificity of CT-AI(Up to 24 months after the index health examination)
- Positive Predictive Value of CT-AI-Assisted Recall(Within 3 months after the index health examination)
- Proportion of Early-Stage Breast Cancers Detected(Within 3 months after the index health examination)
- Physician Recall Rate(Within 3 months after the index health examination)
- Breast Biopsy Rate(Within 3 months after the index health examination)
- 24-Month Interval Breast Cancer Rate(Up to 24 months after the index health examination)