Breast Mapping and Detection of Suspicious Breast Lesions Using Feminai (NCT07220863) | Clinical Trial Compass
RecruitingNot Applicable
Breast Mapping and Detection of Suspicious Breast Lesions Using Feminai
United States300 participantsStarted 2025-10-05
Plain-language summary
Prospective observational study evaluating the safety and accuracy of Feminai 1.0, an at-home adhesive patch that measures skin temperature and electrical impedance to map each breast. Up to 300 women (ages 25-75) undergoing screening will have one study visit; Feminai results will be compared with mammography and, when available, biopsy to assess sensitivity and negative predictive value. Feminai is investigational, intended to support clinical decision-making, and does not replace standard diagnostic tests.
Who can participate
Age range
25 Years – 75 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
. Females aged 25-75 years.
. Able to comply with study procedures and follow-up requirements.
. Willing and able to provide informed consent.
. Presenting for routine mammography/tomosynthesis breast cancer screening according to national/regional guidelines.
. Most recent mammography result - BIRADS 1 or 2
Exclusion criteria
. History of current treatment for breast cancer.
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
Sensitivity and NPV
Timeframe: From enrollment to the time the the ground truth is available followed for up to 6 months
2
Sensitivity and NPV
Timeframe: From enrollment to the time that the mammography and biopsy results (if applicable) are available followed for up to 6 months.
. Any condition that, in the opinion of the investigator, may interfere with the participant's ability to comply with study requirements or may pose a risk to the participant.
. Has breast enhancements (e.g. implants or injections)
. Subjects who have undergone surgery (e.g. lumpectomy or mastectomy) in the last year at the time of study enrollment
. No subject will be allowed to enroll in this trial more than once.
. Cup size larger than E in US-based sizing charts.