- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06352684
Multi-Reader Multi-Case, Retrospective Study to Evaluate Effectiveness of CadAI-B for Breast
April 2, 2024 updated by: BeamWorks Inc.
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
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
CadAI-B for Breast is a real-time 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.
Study Type
Observational
Enrollment (Actual)
1000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Seoul, Korea, Republic of, 03722
- Yonsei University Severance Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
Mainly recruited from a tertiary hospital but no limitation of enrollment
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Cancer group
confirmed as a breast cancer (DCIS or invasive cancer) through the subsequent biopsy conducted within following 1 year of the ultrasound exam.
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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
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CadAI-B for Breast is designed to assist healthcare professionals in lesion detection and differential diagnosis during breast US examinations.
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Normal group
Interpreted as BI-RADS 1 (Negative) with no cancers on the ultrasound exam
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CadAI-B for Breast is designed to assist healthcare professionals in lesion detection and differential diagnosis during breast US examinations.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Area Under the LROC Curve
Time Frame: 6 weeks
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The area under the LROC curve (AUC_LROC) on the diagnosis of suspicious lesions was computed and compared between the aided and unaided sessions.
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6 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lesion detection sensitivity and specificity
Time Frame: 6 weeks
|
The mean sensitivity and specificity of 15 readers were calculated and compared between the aided and unaided sessions.
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 24, 2023
Primary Completion (Estimated)
January 14, 2025
Study Completion (Estimated)
January 14, 2025
Study Registration Dates
First Submitted
April 2, 2024
First Submitted That Met QC Criteria
April 2, 2024
First Posted (Actual)
April 8, 2024
Study Record Updates
Last Update Posted (Actual)
April 8, 2024
Last Update Submitted That Met QC Criteria
April 2, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- DP0001-SEV-CAB-II
- RS-2023-00227526 (Other Grant/Funding Number: Korea Ministry of Science and ICT)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Breast Cancer
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Rutgers, The State University of New JerseyNational Cancer Institute (NCI); Rutgers Cancer Institute of New JerseyActive, not recruitingStage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast CancerUnited States
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University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedMale Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
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University of WashingtonTerminatedBreast Cancer | Breast Cancer Stage I | Breast Cancer Stage II | Breast Cancer Stage III | Breast Cancer Stage IIB | Breast Cancer Stage IIA | Breast Cancer Stage IIIA | Breast Cancer Stage IIIB | Breast Cancer Stage IIIcUnited States
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CelgeneCompletedBreast Cancer | Metastatic Breast Cancer | Stage IV Breast Cancer | Triple-negative Breast Cancer | Recurrent Breast Cancer | Breast Tumor | Cancer of the Breast | Triple-negative Metastatic Breast Cancer | Estrogen Receptor- Negative Breast Cancer | HER2- Negative Breast Cancer | Progesterone Receptor- Negative...United States, United Kingdom, Italy, Germany, Spain, Canada, Portugal, Australia, Austria, Greece, Brazil, France
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University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedHER2-positive Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
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University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Estrogen Receptor-negative Breast Cancer | Estrogen Receptor-positive Breast Cancer | Progesterone Receptor-negative Breast Cancer | Progesterone Receptor-positive Breast...United States
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University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Male Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
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Sidney Kimmel Cancer Center at Thomas Jefferson...Susan G. Komen Breast Cancer FoundationCompletedStage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast CancerUnited States
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Northwestern UniversityEisai Inc.UnknownMale Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative...United States
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Ohio State University Comprehensive Cancer CenterCompletedStage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage IIIC Breast Cancer | Stage III Breast CancerUnited States
Clinical Trials on CadAI-B for Breast
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Samsung Medical CenterRecruitingBreast Cancer | Breast NeoplasmsKorea, Republic of
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Pontificia Universidad Catolica de ChileComisión Nacional de Investigación Científica y TecnológicaRecruitingBreast Cancer | Breast Tumor | Mammary Cancer | Mammary TumorChile
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Taichung Veterans General HospitalRecruiting
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Danish Pain Research CenterDOLORisk Consortium; Aarhus University HospitalCompletedChronic Neuropathic Pain, Postoperative | Chronic Pain, Postoperative | Chronic Chemotherapy-induced Neuropathic Pain | Chronic Chemotherapy-induced Pain | Chronic Chemotherapy-induced Peripheral NeuropathyDenmark
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University of OxfordDepartment of Health, United Kingdom; NHS Cancer Screening ProgrammesCompletedRoutine Mammography
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University of OxfordPublic Health England; Cancer Research UKActive, not recruitingBreast Cancer MortalityUnited Kingdom
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G&G Biotechnology Ltd.RecruitingBreast ImplantsGermany, Israel, Sweden, Switzerland, United Kingdom
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University College, LondonNorthwell Health; Capital Medical University; Scientific Center of ChildrenUnknownVolume of Breast Milk Expressed Using Single Electric Breast Pumps. | Duration of Exclusive Breast-feeding | Duration of Any Breast-feedingUnited Kingdom
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ClasadoCompletedDietary Modification
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Istituti Clinici Scientifici Maugeri SpACompletedBreast Cancer | Radiotherapy Side Effect | Breast Implant; Complications | Breast Implant ProtrusionItaly