Effectiveness of CadAI-B for Breast
유방에 대한 CadAI-B의 유효성을 평가하기 위한 다중 판독기 다중 사례, 후향적 연구
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
연구 개요
상세 설명
CadAI-B for Breast is a real-time artificial intelligence (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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Seoul, 대한민국, 03722
- Yonsei University Severance Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
Mainly recruited from a tertiary hospital but no limitation of enrollment
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: COHORT
- 시간 관점: RETROSPECTIVE
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
Cancer group
confirmed as a breast cancer (ductal carcinoma in situ (DCIS) or invasive cancer) through the subsequent biopsy conducted within following 1 year of the ultrasound exam. |
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 |
CadAI-B for Breast is designed to assist healthcare professionals in lesion detection and differential diagnosis during breast US examinations. |
|
Normal group
Interpreted as Breast Imaging Reporting and Data System (BI-RADS) category 1 (Negative) with no cancers on the ultrasound exam |
CadAI-B for Breast is designed to assist healthcare professionals in lesion detection and differential diagnosis during breast US examinations. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Area Under the LROC Curve
기간: 6 weeks
|
Area Under the Localization Receiver Operating Characteristic (LROC) Curve |
6 weeks
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Lesion detection sensitivity and specificity
기간: 6 weeks
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The mean sensitivity and specificity of 15 readers were calculated and compared between the aided and unaided sessions. |
6 weeks
|
공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .