Breast Mapping and Detection of Suspicious Breast Lesions Using Feminai
Recruiting · NCT07220863 · Observational (researchers observe without assigning treatment) · Lead sponsor: Feminai
View the official record on ClinicalTrials.gov →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.
Who can take part
Age range
25 Years to 75 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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
Exclusion criteria
- 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
1 location listed across 1 US state.
- Solis Mammography Frisco at Stonebriar - Frisco, Texas, United States