Breast CancerNCT06255808
Development of Assist Tool for Breast Examination Using the Principle of Ultrasonic Sensor
An observational study of Breast Cancer and Breast Neoplasm, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The accuracy of breast examinations and ultrasonography performed clinically to detect breast mass varies greatly depending on the physician\'s skill level, and the accuracy of breast examinations by non-experts is particularly low. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Cancer, Breast Neoplasm, Artificial Intelligence
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Oct 2022to 5 Jan 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 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: scheduled for surgery after a tumor has been confirmed on breast ultrasound examination
Who may be able to join
- female patients between 18 and 80 years of age who are scheduled for surgery after a tumor has been confirmed on breast ultrasound examination
Who cannot join
- Patients diagnosed with breast cancer after biopsy with non-mass enhancement or calcification
- Inflammatory breast cancer
- Patients whose cancer has invaded the skin and broken through
- Patients with skin diseases
- Women who refused to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of Assist Tool for Breast Examination Using the Principle of Ultrasonic Sensor : A Development and Validation Study
The accuracy of breast examinations and ultrasonography performed clinically to detect breast mass varies greatly depending on the physician\'s skill level, and the accuracy of breast examinations by non-experts is particularly low. In this study, we aimed to validate whether the concurrent use of ultrasound sensor technology is an efficient strategy for the purpose of improving the sensitivity of detecting breast masses through breast examination.
Read the detailed description
[Background] This research team would like to conduct this study based on the idea that the sensitivity of breast palpation can be improved by moving away from traditional breast palpation, which is simply performed by hand, and using auxiliary examination equipment based on ultrasonic sensor technology. In particular, our research team focused on the waveform of the ultrasound itself rather than the visual images obtained through the ultrasound device. In the existing breast ultrasound, the medical staff reads images created through ultrasound from multiple sensors to confirm the possibility of breast cancer, and this is read based on the medical staff\'s very subjective opinions. However, ultrasonic waveforms acquired through ultrasound can store information about the waveform as data and thus be implemented as objective values.
[Study design] Prospective, multi-institutional
[Study protocol]
① Preoperative ultrasound sensor-based diagnostic equipment was applied to 200 patients with breast mass among patients admitted to the breast surgery department, and prospectively obtained ultrasound echo signal data generated by the mass.
② For this purpose, the researcher uses equipment containing a single ultrasound sensor to manually scan the mass lesion area and no evidence disease area.
③ Diagnostic performance (judgment for presence or absence of a tumor) of diagnostic tool based on ultrasound sensor technology through an artificial intelligence algorithm designed based on ultrasound wavelength and frequency optimized for mass detection.
[Objectives]
- Primary endpoint Sensitivity/specificity/predictive value/accuracy/positive \& negative predictive of diagnostic performance
- Secondary endpoint Artificial intelligence algorithm efficacy
- Conditions
- Breast Cancer, Breast Neoplasm, Artificial Intelligence, Ultrasonography, Benign Breast Disease
- Medical subject headings
- Breast Neoplasms, Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasonic group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device performance
Sensitivity/specificity/predictive value/accuracy/positive predictive value/ negative predictive value of diagnostic performance
Measured: Within 1 year after the study participant registration deadline
Secondary outcomes (1)
Artificial intelligence algorithm efficacy
Measured: Within 2 year after the study participant registration deadline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start5 Oct 2022
- Primary completion5 Jan 2024
- Study completion5 Jan 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.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyeong-Gon Moon, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06255808
- Sponsor's protocol ID
- 2209-039-1357
- Status last verified
- Oct 2026
- First submitted
- 4 Feb 2024
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Assist Tool for Breast Examination Using the Principle of Ultrasonic Sensor : A Development and Validation Study
- ClinicalTrials.gov ID
- NCT06255808
- Acronym / sponsor ID
- 2209-039-1357
- Conditions
- Breast Cancer, Breast Neoplasm, Artificial Intelligence, Ultrasonography, Benign Breast Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 5 Oct 2022 (actual)
- Primary completion
- 5 Jan 2024 (actual)
- Study completion
- 5 Jan 2025 (actual)
- First posted
- 13 Feb 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 accuracy of breast examinations and ultrasonography performed clinically to detect breast mass varies greatly depending on the physician\'s skill level, and the accuracy of breast examinations by non-experts is particularly low. In this study, we aimed to validate whether the concurrent use of ultrasound sensor technology is an efficient strategy for the purpose of improving the sensitivity of detecting breast masses through breast examination.
Detailed description
[Background] This research team would like to conduct this study based on the idea that the sensitivity of breast palpation can be improved by moving away from traditional breast palpation, which is simply performed by hand, and using auxiliary examination equipment based on ultrasonic sensor technology. In particular, our research team focused on the waveform of the ultrasound itself rather than the visual images obtained through the ultrasound device. In the existing breast ultrasound, the medical staff reads images created through ultrasound from multiple sensors to confirm the possibility of breast cancer, and this is read based on the medical staff\'s very subjective opinions. However, ultrasonic waveforms acquired through ultrasound can store information about the waveform as data and thus be implemented as objective values.
[Study design] Prospective, multi-institutional
[Study protocol]
① Preoperative ultrasound sensor-based diagnostic equipment was applied to 200 patients with breast mass among patients admitted to the breast surgery department, and prospectively obtained ultrasound echo signal data generated by the mass.
② For this purpose, the researcher uses equipment containing a single ultrasound sensor to manually scan the mass lesion area and no evidence disease area.
③ Diagnostic performance (judgment for presence or absence of a tumor) of diagnostic tool based on ultrasound sensor technology through an artificial intelligence algorithm designed based on ultrasound wavelength and frequency optimized for mass detection.
[Objectives]
- Primary endpoint Sensitivity/specificity/predictive value/accuracy/positive \& negative predictive of diagnostic performance
- Secondary endpoint Artificial intelligence algorithm efficacy
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultrasonic group | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- scheduled for surgery after a tumor has been confirmed on breast ultrasound examination
Key inclusion criteria (1 listed)
- female patients between 18 and 80 years of age who are scheduled for surgery after a tumor has been confirmed on breast ultrasound examination
Key exclusion criteria (5 listed)
- Patients diagnosed with breast cancer after biopsy with non-mass enhancement or calcification
- Inflammatory breast cancer
- Patients whose cancer has invaded the skin and broken through
- Patients with skin diseases
- Women who refused to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Device performance
Time frame: Within 1 year after the study participant registration deadline
Sensitivity/specificity/predictive value/accuracy/positive predictive value/ negative predictive value of diagnostic performance
1 secondary outcome
Artificial intelligence algorithm efficacy
Time frame: Within 2 year after the study participant registration deadline
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 6 Oct 2026.
- 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.
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 and Breast Neoplasm, run by Seoul National University Hospital 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 1 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 6 Oct 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?
Device performance (time frame: Within 1 year after the study participant registration deadline). 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 6 Oct 2026.