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KNUCH CadAI-B-1(KCB-1)

NCT06622967 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-10-02

No results posted yet for this study

Summary

The CadAI-B (Computer Aided Design Artificial Intelligence-Breast) system is a real-time AI diagnostic tool for breast ultrasound. It integrates with ultrasound devices to detect suspicious lesions, providing size, BI-RADS, and malignancy probability. After installation and user training, the system displays real-time breast conditions and automatically analyzes lesions when a freeze frame is set, showing results in seconds. This study will assess CadAI-B\'s accuracy and reliability by comparing its findings with biopsy results.

Conditions

  • Breast Neoplasm
  • Female

Interventions

DIAGNOSTIC_TEST

CadAI-B

The ultrasound is performed following the usual process. If there are any lesions or areas of concern identified by the patient, a more detailed analysis is conducted on the affected area. When a lesion is confirmed, the examiner verifies the results through the frozen image, while also securing the results displayed on CadAI-B. The examiner uses the analysis from CadAI-B as a reference to make the final BI-RADS classification. Static images and cine clips are captured from the most suspicious areas.

Sponsors & Collaborators

  • Kyungpook National University Chilgok Hospital

    collaborator OTHER

  • BeamWorks Inc.

    collaborator INDUSTRY

  • JeeYeon Lee

    lead OTHER

Principal Investigators

  • Jeeyeon Lee, MD, PhD · Kyungpook National University Chilgok Hospital

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-15
Primary Completion
2024-10-31
Completion
2024-12-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06622967 on ClinicalTrials.gov