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OpenTrials
Active, Not Recruiting

NCT Number: NCT06622967

KNUCH CadAI-B-1(KCB-1)

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Breast Neoplasm Breast Diseases Breast Neoplasms Female Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kyungpook National University Chilgok Hospital

Daegu, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Lesion and Per-patient Diagnostic Performance

    Time frame: At the end of the trial, up to 6 months

    AUC (Area Under the Curve), Sensitivity, Specificity

Secondary outcomes

  1. Lesion and Per-patient Detection Performance

    Time frame: At the end of the trial, up to 6 months

    Sensitivity, Specificity

Other outcomes

  1. BeamWorks Usability Evaluation Scale (Score of BeamWorks System Usability Scale (SUS))

    Time frame: At the end of the trial, up to 6 months

    12~30 : Unacceptable, 30~40 :Marginal, >40:Acceptable

Sponsors and collaborators

Lead sponsor

JeeYeon Lee

Other

Collaborators

  • BeamWorks Inc.
  • Kyungpook National University Chilgok Hospital

Registry information

Official study title

Multinational Clinical Trial of Real-time Artificial Intelligence System (CadAI-B) for Breast Ultrasound: Prospective Clinical Validation Study

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 2, 2024
Registry last updated
Oct 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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