Breast CancerNCT07287111
Effectiveness of CadAI-B Dx for Decision Support in Breast Ultrasound
A study testing CadAI-B Dx in people with Breast Cancer and Breast Neoplasms, run by BeamWorks Inc. at 1 site in South Korea.
Trial summary
This is a retrospective, fully-crossed, multi-reader, multi-case (MRMC) study to evaluate the effectiveness of 'CadAI-B Dx' (CadAI-B) for decision support in breast ultrasound. The study compares the diagnostic performance of readers interpreting breast ultrasound images with and without the aid of CadAI-B. Read more about this study
- Who is it for?
- Ages 22 years and older, women only
- Conditions the study is for
- Breast Cancer, Breast Neoplasms
- What is being tested?
- CadAI-B Dx
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 797 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Aug 2025to 28 Jul 2026
- 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 22 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged 22 years or older at the time of the breast ultrasound examination.
- Standard B-mode breast ultrasound images available for analysis.
- Lesions must have a confirmed diagnosis based on one of the following reference standards:
- 3-1. Malignant Cases: Diagnosis of breast cancer confirmed through biopsy or surgery.
- 3-2. Benign Cases: Confirmed as benign through biopsy or surgical excision, or confirmed as having no evidence of malignancy for at least 2 years of follow-up.
Who cannot join
- mages containing modes other than standard B-mode ultrasound, such as Doppler, elastography, or other annotations/overlays.
- Patients who have breast implant(s).
- Patients suffering from significant breast trauma or mastitis at the time of the breast ultrasound examination.
- Images of post-surgical resection sites.
- Images where multiple lesions are present within a single 2D ultrasound image
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multi-Reader Multi-Case, Cross-Over, Retrospective Study to Evaluate the Effectiveness of CadAI-B Dx for Decision Support in Breast Ultrasound
This is a retrospective, fully-crossed, multi-reader, multi-case (MRMC) study to evaluate the effectiveness of 'CadAI-B Dx' (CadAI-B) for decision support in breast ultrasound. The study compares the diagnostic performance of readers interpreting breast ultrasound images with and without the aid of CadAI-B. A total of 797 patient cases will be included, comprising 350 cases with a confirmed diagnosis of malignancy and 447 cases with a confirmed benign diagnosis. Sixteen readers will participate in the study to evaluate the device.
Read the detailed description
The study utilizes a crossover design where all readers independently review all cases. The control arm consists of a reading session where participating readers independently review cases without the assistance of the CadAI-B device (unaided reading). The experimental arm involves reading with CadAI-B assistance (AI-aided reading). To minimize potential bias, a washout period of four weeks will be maintained between the unassisted and assisted reading sessions for each reader. The primary hypothesis is that CadAI-B assistance significantly improves overall reader performance in breast ultrasound interpretation, as measured by the area under the Localization Receiver Operating Characteristic (LROC) curve (AULROC).
- Conditions
- Breast Cancer, Breast Neoplasms
- Being tested
- CadAI-B Dx
- 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 DxDevice
CadAI-B Dx is a Software as a Medical Device (SaMD) designed to assist physicians by providing Computer-Aided Detection (CADe) and Diagnosis (CADx) capabilities in breast ultrasound interpretation. The software automatically processes the image to identify suspicious regions (Lesion Detection) and provides a quantitative malignancy score (CadAI-Score) mapped to a corresponding BI-RADS Category. It also analyzes lesion size and BI-RADS lexicon descriptors.
| Study group | Role | What they receive |
|---|---|---|
| CadAI- Dx(AI) Unaided Reading | No intervention | Readers evaluate each ultrasound image without access to AI assistance. Readers use only the provided radiological images and their professional clinical expertise to determine their final diagnosis and relevant findings |
| CadAI-DX (AI)-aided Reading | Experimental | Readers have access to CadAI-B's decision-support outputs, which include a pixel-level heatmap (CadAI-Map), auto-segmented lesion boundary, BI-RADS lexicon descriptors, a suggested malignancy probability score (CadAI-Score), and BI-RADS category. Receives: Device: CadAI-B Dx |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Localization Receiver Operating Characteristic (LROC) Curve (AULROC)
The difference in reader performance between the unaided and AI-aided sessions (using CadAI-B Dx) in breast ultrasound interpretation. LROC reflects both detection accuracy and localization precision. The primary hypothesis is that the mean AULROC of all readers for the AI-aided reading mode is greater than that for the unaided reading mode.
Measured: Through study completion, approximately 2 months
Secondary outcomes (8)
Sensitivity
Comparison of the average sensitivity of the readers between the unaided and AI-aided sessions.
Measured: Through study completion, approximately 2 months
Specificity Description
Comparison of the average specificity of the readers between the unaided and AI-aided sessions.
Measured: Through study completion, approximately 2 months
Positive Predictive Value (PPV)
Comparison of PPV between unaided and AI-aided sessions. The PPV will be adjusted for disease prevalence in the target population to reflect real-world clinical practice.
Measured: Through study completion, approximately 2 months
Negative Predictive Value (NPV)
Comparison of NPV between unaided and AI-aided sessions. The NPV will be adjusted for disease prevalence in the target population.
Measured: Through study completion, approximately 2 months
Operating Point Performance Description
Localization-correct true-positive fraction (TPF loc) at fixed false-positive fraction (FPF) rates.
Measured: Through study completion, approximately 2 months
Inter-reader Agreement
Evaluation of the consistency of interpretations among different readers. Inter-reader agreement for BI-RADS category and descriptors assignments will be compared between sessions using Multi-rater Weighted Kappa (for ordinal categories) and Fleiss' Kappa (for descriptors). Time Frame: Through study completion, approximately 2 months
Measured: Through study completion, approximately 2 months
Reading Time
Comparison of the average reading time per case between the unaided and AI-aided sessions to assess if the AI system improves the efficiency of interpretation.
Measured: Through study completion, approximately 2 months
AI-Ground Truth Agreement
Assessment of the agreement between the AI system's outputs and the ground truth. This includes agreement on BI-RADS categories and descriptors (using Weighted/Fleiss Kappa statistics and Accuracy [proportion of exact matches]) and lesion size measurements (using Intraclass Correlation Coefficient).
Measured: Through study completion, approximately 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start30 Aug 2025
- Primary completion7 Oct 2025
- Study completion28 Jul 2026
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Retrospective, fully-crossed, Multi-Reader Multi-Case (MRMC) study.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 797 participants (actual)
Sponsor and investigators
- Lead sponsor
- BeamWorks Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07287111
- Sponsor's protocol ID
- IP0014-US-CAB-I
- Status last verified
- Sep 2026
- First submitted
- 11 Dec 2025
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: ndividual participant data will not be shared to protect proprietary information and subject confidentiality.
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, Cross-Over, Retrospective Study to Evaluate the Effectiveness of CadAI-B Dx for Decision Support in Breast Ultrasound
- ClinicalTrials.gov ID
- NCT07287111
- Acronym / sponsor ID
- IP0014-US-CAB-I
- Conditions
- Breast Cancer, Breast Neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 797 participants (actual)
- Lead sponsor
- BeamWorks Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Aug 2025 (actual)
- Primary completion
- 7 Oct 2025 (actual)
- Study completion
- 28 Jul 2026 (actual)
- First posted
- 17 Dec 2025 (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.
This is a retrospective, fully-crossed, multi-reader, multi-case (MRMC) study to evaluate the effectiveness of 'CadAI-B Dx' (CadAI-B) for decision support in breast ultrasound. The study compares the diagnostic performance of readers interpreting breast ultrasound images with and without the aid of CadAI-B. A total of 797 patient cases will be included, comprising 350 cases with a confirmed diagnosis of malignancy and 447 cases with a confirmed benign diagnosis. Sixteen readers will participate in the study to evaluate the device.
Detailed description
The study utilizes a crossover design where all readers independently review all cases. The control arm consists of a reading session where participating readers independently review cases without the assistance of the CadAI-B device (unaided reading). The experimental arm involves reading with CadAI-B assistance (AI-aided reading). To minimize potential bias, a washout period of four weeks will be maintained between the unassisted and assisted reading sessions for each reader. The primary hypothesis is that CadAI-B assistance significantly improves overall reader performance in breast ultrasound interpretation, as measured by the area under the Localization Receiver Operating Characteristic (LROC) curve (AULROC).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Retrospective, fully-crossed, Multi-Reader Multi-Case (MRMC) study.
| Arm | Type | Receives |
|---|---|---|
| CadAI- Dx(AI) Unaided Reading | No intervention | –Readers evaluate each ultrasound image without access to AI assistance. Readers use only the provided radiological images and their professional clinical expertise to determine their final diagnosis and relevant findings |
| CadAI-DX (AI)-aided Reading | Experimental | Device: CadAI-B DxReaders have access to CadAI-B's decision-support outputs, which include a pixel-level heatmap (CadAI-Map), auto-segmented lesion boundary, BI-RADS lexicon descriptors, a suggested malignancy probability score (CadAI-Score), and BI-RADS category. |
Who may qualify
- Ages
- 22 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women aged 22 years or older at the time of the breast ultrasound examination.
- Standard B-mode breast ultrasound images available for analysis.
- Lesions must have a confirmed diagnosis based on one of the following reference standards:
- 3-1. Malignant Cases: Diagnosis of breast cancer confirmed through biopsy or surgery.
- 3-2. Benign Cases: Confirmed as benign through biopsy or surgical excision, or confirmed as having no evidence of malignancy for at least 2 years of follow-up.
Key exclusion criteria (5 listed)
- mages containing modes other than standard B-mode ultrasound, such as Doppler, elastography, or other annotations/overlays.
- Patients who have breast implant(s).
- Patients suffering from significant breast trauma or mastitis at the time of the breast ultrasound examination.
- Images of post-surgical resection sites.
- Images where multiple lesions are present within a single 2D ultrasound image
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 DxCadAI-B Dx is a Software as a Medical Device (SaMD) designed to assist physicians by providing Computer-Aided Detection (CADe) and Diagnosis (CADx) capabilities in breast ultrasound interpretation. The software automatically processes the image to identify suspicious regions (Lesion Detection) and provides a quantitative malignancy score (CadAI-Score) mapped to a corresponding BI-RADS Category. It also analyzes lesion size and BI-RADS lexicon descriptors. | Device | CadAI-DX (AI)-aided Reading |
Primary outcome
Area Under the Localization Receiver Operating Characteristic (LROC) Curve (AULROC)
Time frame: Through study completion, approximately 2 months
The difference in reader performance between the unaided and AI-aided sessions (using CadAI-B Dx) in breast ultrasound interpretation. LROC reflects both detection accuracy and localization precision. The primary hypothesis is that the mean AULROC of all readers for the AI-aided reading mode is greater than that for the unaided reading mode.
8 secondary outcomes
Sensitivity
Time frame: Through study completion, approximately 2 months
Specificity Description
Time frame: Through study completion, approximately 2 months
Positive Predictive Value (PPV)
Time frame: Through study completion, approximately 2 months
Negative Predictive Value (NPV)
Time frame: Through study completion, approximately 2 months
Operating Point Performance Description
Time frame: Through study completion, approximately 2 months
Inter-reader Agreement
Time frame: Through study completion, approximately 2 months
Reading Time
Time frame: Through study completion, approximately 2 months
AI-Ground Truth Agreement
Time frame: Through study completion, approximately 2 months
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.
- Individual participant dataSharing planned: No. ndividual participant data will not be shared to protect proprietary information and subject confidentiality.
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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?
A study testing CadAI-B Dx in people with Breast Cancer and Breast Neoplasms, 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 5 inclusion and 5 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 Localization Receiver Operating Characteristic (LROC) Curve (AULROC) (time frame: Through study completion, approximately 2 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 30 Sep 2026.