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

April 2, 2024 updated by: BeamWorks Inc.
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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 03722
        • Yonsei University Severance Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Mainly recruited from a tertiary hospital but no limitation of enrollment

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
CadAI-B for Breast is designed to assist healthcare professionals in lesion detection and differential diagnosis during breast US examinations.
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
CadAI-B for Breast is designed to assist healthcare professionals in lesion detection and differential diagnosis during breast US examinations.
Normal group
Interpreted as BI-RADS 1 (Negative) with no cancers on the ultrasound exam
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area Under the LROC Curve
Time Frame: 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.
6 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BeamWorks Inc.

Collaborators

Severance Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 24, 2023

Primary Completion (Estimated)

January 14, 2025

Study Completion (Estimated)

January 14, 2025

Study Registration Dates

First Submitted

April 2, 2024

First Submitted That Met QC Criteria

April 2, 2024

First Posted (Actual)

April 8, 2024

Study Record Updates

Last Update Posted (Actual)

April 8, 2024

Last Update Submitted That Met QC Criteria

April 2, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • DP0001-SEV-CAB-II
  • RS-2023-00227526 (Other Grant/Funding Number: Korea Ministry of Science and ICT)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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