Breast CancerNCT06352684
Effectiveness of CadAI-B for Breast
An observational study of Breast Cancer, run by BeamWorks Inc. at 1 site in South Korea.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 19 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- CadAI-B for Breast
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 24 Nov 2023to 21 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Mainly recruited from a tertiary hospital but no limitation of enrollment
Who may be able to join
- 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
Who cannot join
- women who had breast implants
- women who had US images containing artifacts affecting the review of images
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multi-Reader Multi-Case, Retrospective Study to Evaluate Effectiveness of CadAI-B for Breast
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
Read the detailed description
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.
- Conditions
- Breast Cancer
- Being tested
- CadAI-B for Breast
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CadAI-B for BreastDevice
CadAI-B for Breast is designed to assist healthcare professionals in lesion detection and differential diagnosis during breast US examinations.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: CadAI-B for Breast | |
| 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 Receives: Device: CadAI-B for Breast | |
| Normal group | Interpreted as Breast Imaging Reporting and Data System (BI-RADS) category 1 (Negative) with no cancers on the ultrasound exam Receives: Device: CadAI-B for Breast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the LROC Curve
Area Under the Localization Receiver Operating Characteristic (LROC) Curve
Measured: 6 weeks
Secondary outcomes (1)
Lesion detection sensitivity and specificity
The mean sensitivity and specificity of 15 readers were calculated and compared between the aided and unaided sessions.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start24 Nov 2023
- Primary completion1 Jul 2024
- Study completion21 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- BeamWorks Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Severance Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06352684
- Sponsor's protocol ID
- DP0001-SEV-CAB-II
- Other IDs
- RS-2023-00227526
- Status last verified
- Sep 2026
- First submitted
- 2 Apr 2024
- Last updated
- 30 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Reader Multi-Case, Retrospective Study to Evaluate Effectiveness of CadAI-B for Breast
- ClinicalTrials.gov ID
- NCT06352684
- Acronym / sponsor ID
- DP0001-SEV-CAB-II
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- BeamWorks Inc.Industry (pharma, biotech, devices)
- Collaborators
- Severance Hospital
- Study start
- 24 Nov 2023 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 21 Aug 2025 (actual)
- First posted
- 8 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cancer group | – | Device: CadAI-B for Breastconfirmed 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. |
| Benign group | – | Device: CadAI-B for BreastEither 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 |
| Normal group | – | Device: CadAI-B for BreastInterpreted as Breast Imaging Reporting and Data System (BI-RADS) category 1 (Negative) with no cancers on the ultrasound exam |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Mainly recruited from a tertiary hospital but no limitation of enrollment
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- women who had breast implants
- women who had US images containing artifacts affecting the review of images
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CadAI-B for BreastCadAI-B for Breast is designed to assist healthcare professionals in lesion detection and differential diagnosis during breast US examinations. | Device | Benign group, Cancer group, Normal group |
Primary outcome
Area Under the LROC Curve
Time frame: 6 weeks
Area Under the Localization Receiver Operating Characteristic (LROC) Curve
1 secondary outcome
Lesion detection sensitivity and specificity
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by BeamWorks Inc. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the LROC Curve (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.