ISRCTN18056078已完成未知
A retrospective multi-centre clinical investigation of a novel medical technology solution in the assessment of mammography images
Kheiron Medical Technologies0 个研究点目标入组 1,000,000 人开始时间: 2019年3月20日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 1,000,000
研究概览
简要总结
2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37208717/ (added 22/05/2023)
研究设计
- 研究类型
- Observational
入排标准
- 性别
- Female
入选标准
- •Current participant inclusion criteria as of 25/05/2021:
- •1. Female participants
- •2. 4-view mammography cases (with exactly one of each: MLO-R, MLO-L, CC-R, CC-L of the four standard views) produced by certified digital mammography hardware and taken for screening purposes
- •Previous participant inclusion criteria:
- •1. Female patients
- •2. Mammography cases for screening purposes, i.e. cases from:
- •a) patients involved in the national breast screening program (depending on the jurisdiction includes women of age
- •45-73 who are called for examination via a letter by the national health authorities based on the population database),
- •b) women outside the national breast screening program who decided on their own to participate as per standard of
- •3. Cases with images in DICOM format
- •4. Cases with images produced by certified digital mammography hardware
- •5. Cases with one set of all of the 4 standard mammography images (i.e. exactly one of each: MLO-R, MLO-L, CC-R,
- •CC-L) present (no images missing and no extra images)
- •6. Cases with available historical outcome information as specified below*:
- •(Outcome information:
- •Confirmed positive case: malignancy is confirmed by a decisive biopsy, cytology or histology of the surgical specimen
- •within 250 days after the time of the image acquisition date.
- •Confirmed negative case: a negative follow-up result is available at least 34 months after the image acquisition date
- •(with no malignant operation and no malignancy indication in that period.)
- •*This inclusion criteria only applies to sensitivity/specificity analysis (not recall rate analysis)
排除标准
- •Current participant exclusion criteria as of 25/05/2021:
- •1. Male participants
- •2. Participants from whom any image data is used during training, calibration, or testing for the technology development of the deep learning model
- •3. Non-original, magnified, or spot-compressed images
- •Previous participant exclusion criteria:
- •1. Male patients
- •2. Images that are non-original images (e.g. post-processed images)
- •3. Magnified images (in the DICOM file the View Modifier Code Sequence (0054, 0222) has either of the values: R-
- •102D6, Magnification” or R-102D7, Spot compression”)
- •4. Cases with indication of a breast operation due to malignancy in the past medical history
- •5. Cases dated after a breast cancer confirmed by biopsy, cytology or histology
- •6. All patients of whom any image data was used during training, calibration or testing during the technology
- •development of the deep learning model.
- •Note: hormone replacement therapy in the past medical history is not an exclusion criterion.
研究者
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