A retrospective multi-centre clinical investigation of a novel medical technology solution in the assessment of mammography images

Kheiron Medical Technologies0 sites1,000,000 target enrollmentMarch 20, 2019

Overview

2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37208717/ (added 22/05/2023)

Registry

who.int

Start Date

March 20, 2019

End Date

January 31, 2021

Last Updated

2 years ago

Study Type

Observational

Sex

Female

Sponsor

Kheiron Medical Technologies

•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

•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