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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06352684
• Other study ID #: DP0001-SEV-CAB-II
• Secondary ID: RS-2023-00227526
• Status: Active, not recruiting
• Start date: November 24, 2023
• Est. completion date: January 14, 2025

Study information

• Verified date: April 2024
• Source: BeamWorks Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000
• Est. completion date: January 14, 2025
• Est. primary completion date: January 14, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University Severance Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
BeamWorks Inc.	Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the LROC Curve	The area under the LROC curve (AUC_LROC) on the diagnosis of suspicious lesions was computed and compared between the aided and unaided sessions.	6 weeks
Secondary	Lesion detection sensitivity and specificity	The mean sensitivity and specificity of 15 readers were calculated and compared between the aided and unaided sessions.	6 weeks