Breast Mapping and Detection of Suspicious Breast Lesions Using Feminai

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.

Eligibility

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.

Conditions3

Locations1 site

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