Breast Mapping and Detection of Suspicious Breast Lesions Using Feminai

NCT07220863 | Recruiting

• 1 other identifier: 03-FLTD
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer Awareness

Keywords

Breast lesions; Breast mapping; Home breast examination; Wearable patch; Thermometry; Bioimpedance

Outcome Measures

Primary Outcomes (2)

• Sensitivity and NPV

  From enrollment to the time the the ground truth is available followed for up to 6 months

• Sensitivity and NPV

  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

  From enrollment to the time that the mammography and biopsy results (if applicable) are available followed for up to 6 months.

Study Arms (1)

breast cancer screening

Women between the ages 25-75 undergoing breast cancer screening

Eligibility Criteria

• Age: 25 Years - 75 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Women between the ages 25-75 undergoing breast cancer screening

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.

Sponsors & Collaborators

• Feminai: lead

Study Sites (1)

Solis Mammography Frisco at Stonebriar

Frisco, Texas, 75034, United States

RECRUITING

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2025
• First Posted: October 24, 2025
• Study Start: October 5, 2025
• Primary Completion (Estimated): June 5, 2026
• Study Completion (Estimated): September 5, 2026
• Last Updated: October 24, 2025

Record last verified: 2025-10

Locations

US (1)