Breast Mapping and Detection of Suspicious Breast Lesions Using Feminai
ConditionBreast Cancer Awareness
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age25-75
SponsorFeminai
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Women between the ages 25-75 undergoing breast cancer screening
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
300 Participants
are grouped into 1 trial groupGroup A: breast cancer screening
Trial outcomes
Primary outcomes
1
Sensitivity and NPV
Time frame
From enrollment to the time the the ground truth is available followed for up to 6 months2
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
Time frame
From enrollment to the time that the mammography and biopsy results (if applicable) are available followed for up to 6 months. Source ClinicalTrials.gov