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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Sensitivity and NPV
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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):
- •1. Presenting for biopsy following BIRADS 4-5 mammogram
排除标准
- •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.
结局指标
主要结局
Sensitivity and NPV
时间窗: 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
次要结局
未报告次要终点