Breast Mapping and Detection of Suspicious Breast Lesions Using Feminai

Recruiting now

Conditions studied: Breast Cancer Awareness

In brief

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.

Key facts

Study ID

NCT07220863

Run by

Feminai

People needed

300

Starts

2025-10-05

Expected to finish

2026-09-05

Last updated by the study team

2025-10-24

Who can join

Age: 25 and older, up to 75. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• General:
• Females aged 25-75 years.
• Able to comply with study procedures and follow-up requirements.
• Willing and able to provide informed consent.
• Additional for Group 1 (up to N=150):
• Presenting for routine mammography/tomosynthesis breast cancer screening according to national/regional guidelines.
• Most recent mammography result - BIRADS 1 or 2
• Additional for Group 2 (up to N=150):
• Presenting for biopsy following BIRADS 4-5 mammogram

You may not qualify if…

• History of current treatment for breast cancer.
• Pregnancy or lactation.
• Presence of any implanted metal.
• 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.

Where it is running

• Solis Mammography Frisco at Stonebriar — Frisco, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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