Study of iBreast, a Handheld Device to Detect Breast Abnormalities During Screening Visits for Breast Cancer
不适用
已完成
NCT04761055
| 适应症 | Breast Screening |
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| 分期 | 不适用 |
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| 申办方 | Memorial Sloan Kettering Cancer Center |
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| 状态 | 已完成 |
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| 受试者人数 | 300 人 |
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| 干预(药物) | Clinical Breast exam (CBE), iBreastExam device, mammogram |
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| 开始日期 | 2021年1月29日 |
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| 完成日期 | 2025年8月19日 |
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| 结果公布日 | 2026年7月30日 |
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摘要
This study will test the iBreastExam device to find out whether it can detect a mass or lump in the breast as accurately as a routine breast cancer screening examination. The iBreastExam is a handheld device that performs a painless electronic palpation (examination by touch) of the breast. The device is designed to detect breast abnormalities that may require breast imaging and additional clinical examination by a nurse or doctor. The iBreastExam device creates a color map of the breast, with red spots indicating areas that may be abnormal.
Compare the Outcomes of the iBE Examinations to Clinical Breast Examinations (CBE)by Estimating the Sensitivity of the Device Using Imaging Results
approximately one month after imaging scan · % of true positive breast lesions
| Screening Visits for Breast Cancer | 0.111 % of true positive breast lesions |
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| Screening Visits for Breast Cancer | 0.111 % of true positive breast lesions |
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Compare the Outcomes of the iBE Examinations to Clinical Breast Examinations by Estimating the Specificity of the Device Using Imaging Results
approximately one month after imaging scan · % of true negative lesions
| Screening Visits for Breast Cancer | 1.000 % of true negative lesions |
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| Screening Visits for Breast Cancer | 0.997 % of true negative lesions |
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本页整理自 ClinicalTrials.gov 的公开数据,不构成医疗建议,也不构成投资建议。请务必咨询专业医师。