KNUCH CadAI-B-1(KCB-1)

NCT06622967 | Active Not Recruiting

• 2 other identifiers: KNUCH IRB number : 2024-05-026Digital healthcare demonstrati
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

breast neoplasm; ultrasound

Outcome Measures

Primary Outcomes (1)

• Lesion and Per-patient Diagnostic Performance

  AUC (Area Under the Curve), Sensitivity, Specificity

  At the end of the trial, up to 6 months

Secondary Outcomes (1)

• Lesion and Per-patient Detection Performance

  At the end of the trial, up to 6 months

Other Outcomes (1)

• BeamWorks Usability Evaluation Scale (Score of BeamWorks System Usability Scale (SUS))

  At the end of the trial, up to 6 months

Study Arms (1)

CadAI-B intervention group

EXPERIMENTAL

Participants in this arm will receive the CadAI-B system for the detection of lesions. The AI-based tool will assist healthcare professionals in identifying lesions through enhanced image analysis.

Diagnostic Test: CadAI-B

Interventions

CadAI-B DIAGNOSTIC_TEST

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.

CadAI-B intervention group

Eligibility Criteria

• Age: 20 Years+
• Gender Eligibility Details: Only female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged 20 years or older
• Individuals scheduled to undergo breast ultrasound for diagnostic evaluation
• Patients whose Ground Truth can be determined through biopsy, surgery, or follow-up

You may not qualify if:

• Images containing artifacts that may affect the interpretation
• Presence of breast implants
• Significant breast trauma or mastitis at the time of the breast ultrasound that could cause distortion in image interpretation
• History of surgery or chemotherapy

Sponsors & Collaborators

• JeeYeon Lee: lead
• Kyungpook National University Chilgok Hospital: collaborator
• BeamWorks Inc.: collaborator

Study Sites (1)

Kyungpook National University Chilgok Hospital

Daegu, South Korea

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jeeyeon Lee, MD, PhD

  Kyungpook National University Chilgok Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: September 17, 2024
• First Posted: October 2, 2024
• Study Start: September 15, 2024
• Primary Completion: October 31, 2024
• Study Completion: December 31, 2024
• Last Updated: October 2, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)