NCT05024591

Artificial Intelligence for breaST canceR scrEening in mAMmography (AI-STREAM)

Artificial Intelligence for breaST canceR scrEening in mAMmography (AI-STREAM): A Prospective, Multicenter Cohort Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 25,008 (actual)
• Sponsor: Kyung Hee University Hospital at Gangdong · Academic / Other
• Sex: Female
• Age: 40 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

This prospective study aims to generate real-world evidence on the overall benefits and disadvantages of using Lunit INSIGHT MMG AI based CADe/x for breast cancer detection in a population-based breast cancer screening program in Korea.

Detailed description

1. Several challenges have been identified in breast cancer screening: 1) Some breast cancer cases not identified through screening; 2) Excessive recalls for further testing; 3) Low sensitivity in dense breasts; 4) Inter-reader variability. AI-based CADe/x has been shown to improve radiologist performance and provides results equivalent or superior to those from radiologists alone. 2. This multicenter, prospective study involves women who visit sites for breast cancer screening in Korea. Women eligible for national cancer screening in the relevant year who read the study participant recruitment brochure and read and sign the Participant Information Sheet and Informed Consent Form will be recruited into this study. Approximately 32,714 participants will be enrolled from February 2021 through December 2022 at five study sites in Korea. 3. In Korea, a single radiologist performs mammogram readings. If recall is required (per usual care), further diagnostic work-up will be conducted to confirm cancer detected at screening. The national cancer registry databases will be reviewed in 2026 and 2027. Available findings will be recorded for all participants regardless of their screening status to identify study participants with breast cancer diagnosis within one year and within two years from screening. 4. In primary outcome measurement, as part of the standard screening procedure, mammograms will be read and recorded by a breast radiologist without AI-CADe/x, and then with AI-based CADe/x. \[Set1\] 5. In secondary outcome measurement, mammograms from the same participants as Set 1 will be read and recorded by a general radiologist without AI-based CADe/x, and then with AI-based CADe/x. \[Set 2\] In additional secondary outcome measurement, arbitration reading will be conducted by another breast radiologist without AI-based CADe/x for cases in which the reading results of the two radiologists without AI-based CADe/x in Set 1 and Set 2 are inconsistent. \[Set 3\] 6. After completing the standard screening procedure in Set 1, several situational comparison groups \[Set2 and Set3\] for comparison the diagnostic accuracy will be performed independently and retrospectively The results from Set 2 and Set 3 will not impact the clinical decision(s) associated with the care of the study participants.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DEVICE	Lunit INSIGHT MMG CADe/x for medical imaging	• A software that detects areas suspected of breast cancer using mammographic images, marks areas suspected of malignant lesions, and displays the probability of malignant lesions to assist with the interpreting physician's diagnosis

Timeline

• Start date: 2021-02-01
• Primary completion: 2022-12-31
• Completion: 2024-12-31
• First posted: 2021-08-27
• Last updated: 2023-09-28

Locations

5 sites across 1 country: South Korea