Multi-Reader Multi-Case, Retrospective Study to Evaluate Effectiveness of CadAI-B for Breast

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06352684

Enrollment

1000

Registered

2024-04-08

Start date

2023-11-24

Completion date

2025-01-14

Last updated

2024-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Brief summary

The purpose of this study is to evaluate the effectiveness of lesion detection and diagnosis-aiding software (CadAI-B for Breast) during ultrasound (US) examination

Detailed description

CadAI-B for Breast is a real-time AI diagnosis system designed to assist healthcare professionals in lesion detection and differential diagnosis during breast US examinations. The primary objective of the study is to evaluate the effectiveness of CadAI-B in the assistance of detection and diagnosis of breast cancer by comparing the clinical performance of physicians before and after using CadAI-B in their ultrasound reading. The secondary objective of this study is to evaluate the sensitivity and specificity using CadAI-B for US examinations.

Interventions

DEVICECadAI-B for Breast

CadAI-B for Breast is designed to assist healthcare professionals in lesion detection and differential diagnosis during breast US examinations.

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

19 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Women who underwent breast US examination * Women with breast cancer (DCIS or invasive cancer) diagnosed via biopsy * Women who had been followed for more than 2 years after initial US examination

Exclusion criteria

* women who had breast implants * women who had US images containing artifacts affecting the review of images

Design outcomes

Primary

Measure	Time frame	Description
Area Under the LROC Curve	6 weeks	The area under the LROC curve (AUC\_LROC) on the diagnosis of suspicious lesions was computed and compared between the aided and unaided sessions.

Secondary

Measure	Time frame	Description
Lesion detection sensitivity and specificity	6 weeks	The mean sensitivity and specificity of 15 readers were calculated and compared between the aided and unaided sessions.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026