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Trial Title:
KNUCH CadAI-B-1(KCB-1)
NCT ID:
NCT06622967
Condition:
Breast Neoplasm
Female
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
breast neoplasm
ultrasound
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
CadAI-B
Description:
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.
Arm group label:
CadAI-B intervention group
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.
Criteria for eligibility:
Criteria:
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
Gender:
Female
Gender based:
Yes
Gender description:
Only female
Minimum age:
20 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Kyungpook National University Chilgok Hospital
Address:
City:
Daegu
Country:
Korea, Republic of
Start date:
September 15, 2024
Completion date:
December 31, 2024
Lead sponsor:
Agency:
JeeYeon Lee
Agency class:
Other
Collaborator:
Agency:
Kyungpook National University Chilgok Hospital
Agency class:
Other
Collaborator:
Agency:
BeamWorks Inc.
Agency class:
Industry
Source:
Kyungpook National University Chilgok Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06622967
