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

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
active not recruiting

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
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 14, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 14, 2025

Completed
Last Updated

April 8, 2024

Status Verified

April 1, 2024

Enrollment Period

1.1 years

First QC Date

April 2, 2024

Last Update Submit

April 2, 2024

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Lesion detection sensitivity and specificity

    6 weeks

Study Arms (3)

Cancer group

confirmed as a breast cancer (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 BI-RADS 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

January 14, 2025

Study Completion

January 14, 2025

Last Updated

April 8, 2024

Record last verified: 2024-04

Locations

KR(1)