[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07220863":3,"trial-entities:NCT07220863":72,"trial-summary:NCT07220863":76},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":27,"primary_purpose":28,"phases":29,"enrollment_info":30,"interventions":33,"primary_outcomes":34,"secondary_outcomes":41,"sex":42,"minimum_age":43,"maximum_age":44,"healthy_volunteers":15,"eligibility_criteria":45,"std_ages":49,"locations":52,"central_contacts":68,"overall_officials":69,"references":70,"see_also_links":71},"NCT07220863","03-FLTD","Breast Mapping and Detection of Suspicious Breast Lesions Using Feminai","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","RECRUITING","2026-09-05","2025-10","2025-10-24","2025-10-05","Feminai","INDUSTRY",false,"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.","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.\n\nWho can join:\n\nWomen ages 25-75 who are undergoing breast cancer screening. Two groups will be enrolled:\n\n* About 150 women whose most recent screening mammogram was read as low concern (similar to BI-RADS 1-2).\n* About 150 women who are scheduled for a biopsy after a mammogram that showed higher concern (similar to BI-RADS 4-5).\n\nKey exclusions include current treatment for breast cancer, pregnancy or breastfeeding, metal implants, recent breast surgery (within 1 year), breast implants\u002Finjections, cup size larger than US size E, and any condition that would make participation unsafe or impractical.\n\nWhat participation involves:\n\nThis 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.\n\nRisks and discomforts:\n\nExpected 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\u002Fsensitivity, especially with repeated applications. Serious device-related risks are not expected but will be monitored. Any device malfunctions will be recorded.",[19],"Breast Cancer Awareness",[21,22,23,24,25,26],"Breast lesions","Breast mapping","Home breast examination","Wearable patch","Thermometry","Bioimpedance","OBSERVATIONAL",null,[],{"count":31,"type":32},300,"ESTIMATED",[],[35,38],{"measure":36,"timeFrame":37},"Sensitivity and NPV","From enrollment to the time the the ground truth is available followed for up to 6 months",{"measure":36,"description":39,"timeFrame":40},"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).\n\nFor side-level analysis, the definitions of True Positive (TP), False Positive (FP), True Negative (TN), and False Negative (FN) are as follows:\n\nTP 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\n\nFor subject-level analysis, the definitions of TP, FP, TN, and FN are based on side-level classification, as follows:\n\nTP 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.\n\nFN 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.",[],"FEMALE","25 Years","75 Years",{"inclusion":46,"exclusion":47,"raw_text":48},[],[],"Inclusion Criteria:\n\nGeneral:\n\n1. Females aged 25-75 years.\n2. Able to comply with study procedures and follow-up requirements.\n3. Willing and able to provide informed consent.\n\nAdditional for Group 1 (up to N=150):\n\n1. Presenting for routine mammography\u002Ftomosynthesis breast cancer screening according to national\u002Fregional guidelines.\n2. Most recent mammography result - BIRADS 1 or 2\n\nAdditional for Group 2 (up to N=150):\n\n1\\. Presenting for biopsy following BIRADS 4-5 mammogram\n\nExclusion Criteria:\n\n1. History of current treatment for breast cancer.\n2. Pregnancy or lactation.\n3. Presence of any implanted metal.\n4. 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.\n5. Has breast enhancements (e.g. implants or injections)\n6. Subjects who have undergone surgery (e.g. lumpectomy or mastectomy) in the last year at the time of study enrollment\n7. No subject will be allowed to enroll in this trial more than once.\n8. Cup size larger than E in US-based sizing charts.",[50,51],"ADULT","OLDER_ADULT",[53],{"facility":54,"status":8,"city":55,"state":56,"zip":57,"country":58,"contacts":59,"geoPoint":65},"Solis Mammography Frisco at Stonebriar","Frisco","Texas","75034","United States",[60],{"name":61,"role":62,"phone":63,"email":64},"Jennifer Pantleo, RN BSN BBA CBCN","CONTACT","214-872-4484","Jennifer.Pantleo@solismammo.com",{"lat":66,"lon":67},33.15067,-96.82361,[],[],[],[],{"nct_id":4,"conditions":73,"biomarkers":75},[74],"Breast Carcinoma",[],{"nct_id":4,"found":77,"summary":78,"prompt_version":88},true,{"design":79,"status":80,"heading":81,"summary":82,"follow_up":83,"word_count":84,"commitments":85,"compensation":86,"drugs_mentioned":87},"This is an observational study involving up to 300 women. It is not specified if it is randomized or blinded.","completed","Breast Mapping with Feminai for Cancer Detection","This study is evaluating Feminai 1.0, an at-home adhesive patch that measures skin temperature and electrical impedance to create a \"map\" of each breast. Researchers want to see if Feminai can help identify suspicious areas that might need further medical checks. The study aims to enroll up to 300 women, aged 25-75, who are already getting breast cancer screenings. Feminai results will be compared to mammograms and, if applicable, biopsy results to see how well it detects suspicious lesions and how accurately it rules them out. Feminai is meant to support doctors' decisions and does not replace standard diagnostic tests. The study's success will be measured by how accurately Feminai identifies (sensitivity) and rules out (negative predictive value) suspicious lesions.","You would be followed for up to 6 months after enrollment to compare Feminai results with mammography and biopsy results.",120,"You would have one study visit where trained staff apply the Feminai patch to your breasts and you complete a short questionnaire.","Not stated in the trial record.",[],"v2"]