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.
Eligibility
Sex
FEMALE
Min age
25 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
General:
1. Females aged 25-75 years.
2. Able to comply with study procedures and follow-up requirements.
3. Willing and able to provide informed consent.
Additional for Group 1 (up to N=150):
1. Presenting for routine mammography/tomosynthesis breast cancer screening according to national/regional guidelines.
2. Most recent mammography result - BIRADS 1 or 2
Additional for Group 2 (up to N=150):
1\. Presenting for biopsy following BIRADS 4-5 mammogram
Exclusion Criteria:
1. History of current treatment for breast cancer.
2. Pregnancy or lactation.
3. Presence of any implanted metal.
4. 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.
5. Has breast enhancements (e.g. implants or injections)
6. Subjects who have undergone surgery (e.g. lumpectomy or mastectomy) in the last year at the time of study enrollment
7. No subject will be allowed to enroll in this trial more than once.
8. Cup size larger than E in US-based sizing charts.
Primary outcome measure(s)
Sensitivity and NPV — From enrollment to the time the the ground truth is available followed for up to 6 months
Sensitivity and NPV — From enrollment to the time that the mammography and biopsy results (if applicable) are available followed for up to 6 months. The co-primary endpoints will be defined on a per patient basis as sensitivity and NPV. The endpoints will be based on the binary outcomes produced for each breast side (right and left).
For side-level analysis, the definitions of True Positive (TP), False Positive (FP), True Negative (TN), and False Negative (FN) are as follows:
TP side: Side is Ground Truth (GT) positive and Flagged by device FP side: Side is GT negative and Flagged by device FN side: Side is GT positive and Not Flagged by device TN side: Side is GT negative and Not Flagged by device
For subject-level analysis, the definitions of TP, FP, TN, and FN are based on side-level classification, as follows:
TP subject: A subject has only one GT positive side and this side is Flagged by the device. Or, a subject has 2 GT positive sides and at least one side is Flagged by device.
FN subject: A subject has one or two GT positive sides and none of these sides is Flagged by the device FP subject: A subject has both sides GT
Trial sites (1)
Facility
City
Region
Status
Solis Mammography Frisco at Stonebriar
Frisco
Texas
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.