Actively Recruiting
Breast Mapping and Detection of Suspicious Breast Lesions Using Feminai
Led by Feminai · Updated on 2025-10-24
300
Participants Needed
1
Research Sites
47 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Breast Mapping and Detection of Suspicious Breast Lesions Using Feminai
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 25 to 75 years
- Able to comply with study procedures and follow-up
- Willing and able to provide informed consent
- For Group 1: Presenting for routine mammography breast cancer screening as per guidelines
- For Group 1: Most recent mammography result classified as BIRADS 1 or 2
- For Group 2: Scheduled for biopsy following a BIRADS 4 or 5 mammogram
You will not qualify if you...
- Currently undergoing treatment for breast cancer
- Pregnant or breastfeeding
- Presence of any implanted metal
- Any condition that may interfere with study participation or pose risk as judged by investigator
- Has breast enhancements such as implants or injections
- Had breast surgery (e.g., lumpectomy or mastectomy) within the past year
- Previous enrollment in this trial
- Breast cup size larger than US size E
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Solis Mammography Frisco at Stonebriar
Frisco, Texas, United States, 75034
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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