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临床试验/ISRCTN60839016
ISRCTN60839016进行中(未招募)未知

Clinical validation of an artificial intelligence system to improve the quality, efficiency and experience of breast cancer screening

Imperial College London0 个研究点目标入组 68,000 人开始时间: 2022年6月6日最近更新:
适应症

试验速览

阶段
未知
状态
进行中(未招募)
入组人数
68,000

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational

入排标准

性别
Female

入选标准

  • 1. Women undergoing routine breast cancer screening (age 50-70 years) as part of the national breast screening programme from January 2016 onwards
  • 2. Mammography images acquired using Hologic/Lorad, Siemens, or GE devices

排除标准

  • 1. Women attending an assessment clinic or symptomatic clinic (i.e. not routine screening)
  • 2. Women undergoing annual screening due to:
  • 2.1. High risk (lifetime risk >30% - e.g. faulty BRCA1, BRCA2, TP53)
  • 2.2. Moderate risk (lifetime risk 17-30%)
  • 2.3. Personal stratified follow up (e.g. indeterminate B3 lesions)
  • 3. Presence of breast implants
  • 4. Screens with incomplete (<4 standard screening views - e.g. due to abandoned screen)
  • 5. Poor diagnostic quality imaging (which would be repeated)
  • 6. Non-standard acquisitions beyond the routine 4 screening views
  • 7. For negative or benign cases, women without a negative follow up screen approximately 3 years later (at least 31 months after initial screen), as this would preclude determination of a robust ground truth
  • Same dataset as defined in Part A, with the same inclusion and exclusion criteria

研究者

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