Artificial intelligence in mammography study

Not Applicable

• Conditions: Decision support in breast cancer screening; Cancer; Malignant neoplasm of breast

• Registration Number: ISRCTN60839016
• Lead Sponsor: Imperial College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-06-06
• Last Update Posted: 20 June 2022
• Study Completion: 2024-05-21

Recruitment & Eligibility

• Status: Ongoing
• Sex: Female
• Target Recruitment: 68000

Inclusion Criteria

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

Exclusion Criteria

Part A:
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

Part B:
Same dataset as defined in Part A, with the same inclusion and exclusion criteria

Study & Design

• Study Type: Observational
• Study Design: Not specified