Clinical Study to Assess the Safety and Performance of Kenko Breast AI+ Medical Device as an Aid … (NCT07580105) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Clinical Study to Assess the Safety and Performance of Kenko Breast AI+ Medical Device as an Aid to Breast Cancer Diagnosis in Adult Women
Spain200 participantsStarted 2026-05
Plain-language summary
The goal of this observational study is to learn whether a new medical software tool called Kenko Breast AI+ can help healthcare professionals read breast magnetic resonance imaging (MRI) scans better to help diagnose breast cancer. The study includes adult women who may have breast cancer or who are being followed for the disease.
The main questions it aims to answer is:
* Does Kenko Breast AI+ help healthcare professionals find possible signs of breast cancer more accurately and efficiently when they read MRI scans?
* Does using the software cause any safety problems or software-related issues during the study?
Researchers will compare MRI readings done with the software to readings done without it.
Participants will attend their regularly scheduled breast MRI appointment. All diagnoses are based on standard medical care, not on the study software.
Who can participate
Age range
18 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
. Women with suspected breast cancer or under surveillance for the disease who have undergone MRI including perfusion (DCE-MRI), diffusion (DTI-MRI) and T2 sequences, performed for the purposes of:
. Staging,
. Assessment of response to neoadjuvant therapy,
. High suspicion of breast cancer, or
. Follow-up.
. For participants who have undergone MRI for follow-up purposes, prior breast MRI data collected at the most 12 months before the screening visit must be available.
. Women age 18 and older.
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
The False Positive (FP), False Negatives (FN), True Positives (TP), and True Negatives (TN) rates.
Timeframe: Through MRI cases assessment during the study period (Months 1 to 11)
2
Interpretation time.
Timeframe: Through MRI cases assessment during the study period (Months 1 to 11)
3
The occurrence of non-serious and serious device-related, or device procedures-related adverse events, and device deficiencies.
Timeframe: From enrollment through study completion (assessed up to 11 months)