Development of Assist Tool for Breast Examination Using the Principle of Ultrasonic Sensor (NCT06255808) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Development of Assist Tool for Breast Examination Using the Principle of Ultrasonic Sensor
South Korea200 participantsStarted 2024-10-05
Plain-language 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. 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.
Who can participate
Age range
18 Years – 80 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* female patients between 18 and 80 years of age who are scheduled for surgery after a tumor has been confirmed on breast ultrasound examination
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing an ultrasonic sensor-based tool assisted by artificial intelligence for breast examination — could you help me understand whether this device is being evaluated for detecting cancerous findings, benign conditions, or both, and what that means for someone in my situation?
2Since this study is listed as 'active, not recruiting,' it sounds like they're no longer accepting new participants — is there a similar or follow-up study using AI-assisted ultrasound technology that I might be eligible to discuss?
3The trial is measuring 'device performance' rather than patient health outcomes like survival or treatment response — what does that tell us about how early-stage this technology is, and should that affect how much weight I give it compared to standard breast imaging options I already have access to?
4Given that this study involves an experimental ultrasonic sensor tool, how does its diagnostic approach compare to the standard ultrasound or mammography my care team would normally recommend, and is there any reason to consider waiting for more evidence before relying on this type of technology?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Device performance
Timeframe: Within 1 year after the study participant registration deadline