Multicentric Study for External Validation of a Deep Learning Model for Mammographic Breast Densi… (NCT05021055) | Clinical Trial Compass
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Multicentric Study for External Validation of a Deep Learning Model for Mammographic Breast Density Categorization
277 participantsStarted 2021-09
Plain-language summary
The correct categorization of breast density is essential to adapt the diagnostic examination to the needs of each patient. Assessment of breast density is performed visually by radiologists. Some authors have detected that this method involves considerable intra and interobserver variability. On the other hand, automated systems for measuring breast density are becoming more and more frequent. Machine learning is a domain of Artificial Intelligence, which comprises the process of developing systems with the ability to learn and make predictions using data. These systems are designed to aid healthcare professional decision making. In the present work, the multicenter study of external validation of a tool based on deep learning for the categorization of mammographic breast density is proposed.
Who can participate
Sex
ALL
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:
* Mammograms included in the study should meet the following criteria:
* Female patients of 40 years of age or more.
* To have at least one screening mammography exam performed at Saint John's
* Cancer Institute during the study period. These exams will be included regardless of the brand of the mammography equipment.
* Mammograms should be performed with digital equipment.
Exclusion Criteria:
* Mammograms with the following criteria will be excluded from the study:
* Patients with gigantomastia, defined by the need for more than one image of each mammographic view (mediolateral oblique and craniocaudal) to evaluate the entire breast volume.
* Patients with breast implants.
* Patients with a history of breast surgery.
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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
Agreement between the majority report and Artemisia´s categorization of dense breasts/non-dense breasts
Timeframe: 2 months
2
Agreement between the majority report and Artemisia in each one of the four breast density categories