A retrospective multi-centre clinical study of a deep learning system in identifying breast cancer through the assessment of mammograms

Not Applicable

• Conditions: Decision support in breast cancer screening; Cancer

• Registration Number: ISRCTN15504688
• Lead Sponsor: Kheiron Medical Technologies (United Kingdom)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-02-03
• Last Update Posted: 2 August 2023
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: Female
• Target Recruitment: 1000000

Inclusion Criteria

1. Female participants
2. Participants attending for breast screening purposes (normal and opportunistic screening)*
3. Participants for whom a 2D FFDM standard four-view mammography examination was acquired (MLO-R, CC-R, MLO-L, CC-L)
* Includes: 1) early recall cases (e.g. participants brought back for screening earlier than the established screening interval); and 2) participants of UK age extension trial (AgeX).

Exclusion Criteria

Does not meet inclusion criteria

Study & Design

• Study Type: Other
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity of the standalone case-wise malignancy detection performance of Mia, measured as the number of positive cases recalled divided by the total number of positive cases, over the full study dataset time period. Specificity of the standalone case-wise malignancy detection performance of Mia, measured as the number of confirmed negative cases not recalled divided by the total number of confirmed negative cases, over the full dataset time period.