NCT05024591进行中（未招募）不适用
Artificial Intelligence for breaST canceR scrEening in mAMmography (AI-STREAM): A Prospective, Multicenter Cohort Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 25,008
- 试验地点
- 5
- 主要终点
- • Diagnostic accuracy with difference between breast radiologists with and without AI-based CADe/x
研究概览
简要总结
This prospective study aims to generate real-world evidence on the overall benefits and disadvantages of using Lunit INSIGHT MMG AI based CADe/x for breast cancer detection in a population-based breast cancer screening program in Korea.
详细描述
- Several challenges have been identified in breast cancer screening: 1) Some breast cancer cases not identified through screening; 2) Excessive recalls for further testing; 3) Low sensitivity in dense breasts; 4) Inter-reader variability. AI-based CADe/x has been shown to improve radiologist performance and provides results equivalent or superior to those from radiologists alone.
- This multicenter, prospective study involves women who visit sites for breast cancer screening in Korea. Women eligible for national cancer screening in the relevant year who read the study participant recruitment brochure and read and sign the Participant Information Sheet and Informed Consent Form will be recruited into this study. Approximately 32,714 participants will be enrolled from February 2021 through December 2022 at five study sites in Korea.
- In Korea, a single radiologist performs mammogram readings. If recall is required (per usual care), further diagnostic work-up will be conducted to confirm cancer detected at screening. The national cancer registry databases will be reviewed in 2026 and 2027. Available findings will be recorded for all participants regardless of their screening status to identify study participants with breast cancer diagnosis within one year and within two years from screening.
- In primary outcome measurement, as part of the standard screening procedure, mammograms will be read and recorded by a breast radiologist without AI-CADe/x, and then with AI-based CADe/x. [Set1]
- In secondary outcome measurement, mammograms from the same participants as Set 1 will be read and recorded by a general radiologist without AI-based CADe/x, and then with AI-based CADe/x. [Set 2] In additional secondary outcome measurement, arbitration reading will be conducted by another breast radiologist without AI-based CADe/x for cases in which the reading results of the two radiologists without AI-based CADe/x in Set 1 and Set 2 are inconsistent. [Set 3]
- After completing the standard screening procedure in Set 1, several situational comparison groups [Set2 and Set3] for comparison the diagnostic accuracy will be performed independently and retrospectively The results from Set 2 and Set 3 will not impact the clinical decision(s) associated with the care of the study participants.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 100 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participants must meet all of the following inclusion criteria in order to be enrolled in the study:
- •Be eligible for national cancer screening in the relevant year and visit the site for breast cancer screening
- •Provide consent for study participation using the Informed Consent Form and complete a Participant information Sheet
排除标准
- •Participants who meet any of the following criteria will be excluded from the study:
- •Has a history of or current breast cancer
- •Is currently pregnant or plans to become pregnant in the next 12 months
- •Has a history of breast surgery (mammoplasty or insertion of a foreign substance, such as paraffin or silicon)
- •Has mammography for diagnostic purposes
结局指标
主要结局
• Diagnostic accuracy with difference between breast radiologists with and without AI-based CADe/x
时间窗: 12months after screening, 24months after screening
Diagnostic accuracy is assessed using cancer registry data as the reference group to calculate cancer detection rate \[CDR\], recall rate, sensitivity, positive predictive value
次要结局
- • Diagnostic accuracy and difference of the following comparison groups with or without AI(12months after screening, 24 months after screening)
研究者
Jung Kyu Ryu,MD
MD, PhD, Principal Investigator
Kyung Hee University Hospital at Gangdong
研究点 (5)
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