NCT06352684

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 24, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 2, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 8, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 21, 2025

Completed
Last Updated

September 30, 2026

Status Verified

September 1, 2026

Enrollment Period

7 months

First QC Date

April 2, 2024

Last Update Submit

September 28, 2026

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Area Under the LROC Curve

    Area Under the Localization Receiver Operating Characteristic (LROC) Curve

    6 weeks

Secondary Outcomes (1)

  • Lesion detection sensitivity and specificity

    6 weeks

Study Arms (3)

Cancer group

confirmed as a breast cancer (ductal carcinoma in situ (DCIS) or invasive cancer) through the subsequent biopsy conducted within following 1 year of the ultrasound exam.

Device: CadAI-B for Breast

Benign group

Either confirmed as a benign through the subsequent biopsy conducted within following 1 year of the ultrasound exam or showing stability on more than 2 years of imaging follow-up after initial diagnosis

Device: CadAI-B for Breast

Normal group

Interpreted as Breast Imaging Reporting and Data System (BI-RADS) category 1 (Negative) with no cancers on the ultrasound exam

Device: CadAI-B for Breast

Interventions

CadAI-B for BreastDEVICE

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

Benign groupCancer groupNormal group

Eligibility Criteria

Age19 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Mainly recruited from a tertiary hospital but no limitation of enrollment

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yonsei University Severance Hospital

Seoul, 03722, South Korea

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2024

First Posted

April 8, 2024

Study Start

November 24, 2023

Primary Completion

July 1, 2024

Study Completion

August 21, 2025

Last Updated

September 30, 2026

Record last verified: 2026-09

Locations

KR(1)