Breast NeoplasmNCT06622967
KNUCH CadAI-B-1(KCB-1)
A study testing CadAI-B in people with Breast Neoplasm and Female, run by JeeYeon Lee at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Breast Neoplasm, Female
- What is being tested?
- CadAI-B
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Sep 2024to 31 Dec 2024
- Phase
- Interventional
- 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 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multinational Clinical Trial of Real-time Artificial Intelligence System (CadAI-B) for Breast Ultrasound: Prospective Clinical Validation Study
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.
- Conditions
- Breast Neoplasm, Female
- Being tested
- CadAI-B
- Keywords
- breast neoplasm, ultrasound
- 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-BDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| CadAI-B intervention group | Experimental | Participants in this arm will receive the CadAI-B system for the detection of lesions. The AI-based tool will assist healthcare professionals in identifying lesions through enhanced image analysis. Receives: Diagnostic Test: CadAI-B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lesion and Per-patient Diagnostic Performance
AUC (Area Under the Curve), Sensitivity, Specificity
Measured: At the end of the trial, up to 6 months
Secondary outcomes (1)
Lesion and Per-patient Detection Performance
Sensitivity, Specificity
Measured: At the end of the trial, up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start15 Sep 2024
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- JeeYeon Lee
- Sponsor type
- University, hospital or other
- Collaborators
- Kyungpook National University Chilgok Hospital, BeamWorks Inc.
- Responsible party
- Sponsor-investigator, JeeYeon Lee, Kyungpook National University Chilgok Hospital
- Investigators
- Jeeyeon Lee, MD, PhD, Study chair, Kyungpook National University Chilgok Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06622967
- Sponsor's protocol ID
- KNUCH IRB number : 2024-05-026
- Other IDs
- Digital healthcare demonstrati
- Status last verified
- Sep 2024
- First submitted
- 17 Sep 2024
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multinational Clinical Trial of Real-time Artificial Intelligence System (CadAI-B) for Breast Ultrasound: Prospective Clinical Validation Study
- ClinicalTrials.gov ID
- NCT06622967
- Acronym / sponsor ID
- KNUCH IRB number : 2024-05-026
- Conditions
- Breast Neoplasm, Female
- Keywords
- breast neoplasm, ultrasound
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- JeeYeon LeeUniversity, hospital or other
- Collaborators
- Kyungpook National University Chilgok Hospital, BeamWorks Inc.
- Study start
- 15 Sep 2024 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 2 Oct 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 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CadAI-B intervention group | Experimental | Diagnostic Test: CadAI-BParticipants in this arm will receive the CadAI-B system for the detection of lesions. The AI-based tool will assist healthcare professionals in identifying lesions through enhanced image analysis. |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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-BThe 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. | Diagnostic test | CadAI-B intervention group |
Primary outcome
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
1 secondary outcome
Lesion and Per-patient Detection Performance
Time frame: At the end of the trial, up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
- Individual participant dataSharing planned: No
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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.
Jeeyeon Lee, MD, PhD study chair
Kyungpook National University Chilgok Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CadAI-B in people with Breast Neoplasm and Female, run by JeeYeon Lee 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 4 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: status not confirmed, as of the sponsor's last update on 2 Oct 2024. 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?
Results are not available in the source record.
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?
Lesion and Per-patient Diagnostic Performance (time frame: At the end of the trial, up to 6 months). 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 2 Oct 2024.