Breast Cancer AwarenessNCT07220863
Breast Mapping and Detection of Suspicious Breast Lesions Using Feminai
An observational study of Breast Cancer Awareness, run by Feminai at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 75 years, women only
- Conditions the study is for
- Breast Cancer Awareness
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2025to 5 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women between the ages 25-75 undergoing breast cancer screening
Who may be able to join
- 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.
Show all 9Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Solis Mammography Frisco at Stonebriar
Frisco, Texas, 75034
Jennifer Pantleo, RN BSN BBA CBCN, 214-872-4484, Jennifer.Pantleo@solismammo.com
About this study
Official title: Evaluation of the Safety and Efficacy of a Wearable Device Based on Thermometry and Impedance Technology for Breast Mapping and Detecting Suspicious Breast Lesions Using Feminai 1.0
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.
Read the detailed description
This study will evaluate Feminai 1.0, a home breast examination kit that uses skin-surface temperature and electrical impedance measurements to create a "map" of each breast. The goal is to learn whether Feminai can help identify the presence or absence of suspicious soft-tissue lesions that may need further medical evaluation. The device is intended to support clinical decision-making and is not a stand-alone diagnostic test.
Who can join:
Women ages 25-75 who are undergoing breast cancer screening. Two groups will be enrolled:
- About 150 women whose most recent screening mammogram was read as low concern (similar to BI-RADS 1-2).
- About 150 women who are scheduled for a biopsy after a mammogram that showed higher concern (similar to BI-RADS 4-5).
Key exclusions include current treatment for breast cancer, pregnancy or breastfeeding, metal implants, recent breast surgery (within 1 year), breast implants/injections, cup size larger than US size E, and any condition that would make participation unsafe or impractical.
What participation involves:
This is a prospective, observational study with one visit. After informed consent and eligibility confirmation, trained staff will apply the Feminai patch in a private room to collect measurements from each breast. Participants will complete a short questionnaire about their experience. Routine clinical care (such as mammography and, if planned, biopsy) will occur as usual; there is no randomization and no change to standard care. To avoid anxiety or influencing medical decisions, Feminai results will not be shared with participants or their physicians.
Risks and discomforts:
Expected risks are minor and temporary, similar to other adhesive skin patches: mild skin redness or irritation, itching, slight discomfort when the patch is removed, brief indentation marks, or mild dryness/sensitivity, especially with repeated applications. Serious device-related risks are not expected but will be monitored. Any device malfunctions will be recorded.
- Conditions
- Breast Cancer Awareness
- Keywords
- Breast lesions, Breast mapping, Home breast examination, Wearable patch, Thermometry, Bioimpedance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| breast cancer screening | Women between the ages 25-75 undergoing breast cancer screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and NPV
Measured: 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
Measured: From enrollment to the time that the mammography and biopsy results (if applicable) are available followed for up to 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2025
- Study start5 Oct 2025
- Primary completion5 Jun 2026 (estimated)
- Study completion5 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer AwarenessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Feminai
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07220863
- Sponsor's protocol ID
- 03-FLTD
- Status last verified
- Oct 2025
- First submitted
- 21 Oct 2025
- Last updated
- 24 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Efficacy of a Wearable Device Based on Thermometry and Impedance Technology for Breast Mapping and Detecting Suspicious Breast Lesions Using Feminai 1.0
- ClinicalTrials.gov ID
- NCT07220863
- Acronym / sponsor ID
- 03-FLTD
- Conditions
- Breast Cancer Awareness
- Keywords
- Breast lesions, Breast mapping, Home breast examination, Wearable patch, Thermometry, Bioimpedance
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- FeminaiIndustry (pharma, biotech, devices)
- Study start
- 5 Oct 2025 (actual)
- Primary completion
- 5 Jun 2026 (estimated)
- Study completion
- 5 Sep 2026 (estimated)
- First posted
- 24 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study will evaluate Feminai 1.0, a home breast examination kit that uses skin-surface temperature and electrical impedance measurements to create a "map" of each breast. The goal is to learn whether Feminai can help identify the presence or absence of suspicious soft-tissue lesions that may need further medical evaluation. The device is intended to support clinical decision-making and is not a stand-alone diagnostic test.
Who can join:
Women ages 25-75 who are undergoing breast cancer screening. Two groups will be enrolled:
- About 150 women whose most recent screening mammogram was read as low concern (similar to BI-RADS 1-2).
- About 150 women who are scheduled for a biopsy after a mammogram that showed higher concern (similar to BI-RADS 4-5).
Key exclusions include current treatment for breast cancer, pregnancy or breastfeeding, metal implants, recent breast surgery (within 1 year), breast implants/injections, cup size larger than US size E, and any condition that would make participation unsafe or impractical.
What participation involves:
This is a prospective, observational study with one visit. After informed consent and eligibility confirmation, trained staff will apply the Feminai patch in a private room to collect measurements from each breast. Participants will complete a short questionnaire about their experience. Routine clinical care (such as mammography and, if planned, biopsy) will occur as usual; there is no randomization and no change to standard care. To avoid anxiety or influencing medical decisions, Feminai results will not be shared with participants or their physicians.
Risks and discomforts:
Expected risks are minor and temporary, similar to other adhesive skin patches: mild skin redness or irritation, itching, slight discomfort when the patch is removed, brief indentation marks, or mild dryness/sensitivity, especially with repeated applications. Serious device-related risks are not expected but will be monitored. Any device malfunctions will be recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| breast cancer screening | – | –Women between the ages 25-75 undergoing breast cancer screening |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women between the ages 25-75 undergoing breast cancer screening
Key inclusion criteria (9 listed)
- Females aged 25-75 years.
- Able to comply with study procedures and follow-up requirements.
- Willing and able to provide informed consent.
- Presenting for routine mammography/tomosynthesis breast cancer screening according to national/regional guidelines.
- Most recent mammography result - BIRADS 1 or 2
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensitivity and NPV
Time frame: From enrollment to the time the the ground truth is available followed for up to 6 months
Sensitivity and NPV
Time frame: From enrollment to the time that the mammography and biopsy results (if applicable) are available followed for up to 6 months.
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Solis Mammography Frisco at Stonebriar
Frisco, United States
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Awareness, run by Feminai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and NPV (time frame: From enrollment to the time the the ground truth is available followed for up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2025.