Background/Objectives: The iBreast Exam (iBE) electronically palpates the breast to identify possible abnormalities. The purpose of this study was to assess iBE feasibility and compare it to Clinical Breast Exam (CBE) for breast lesion detection.Methods: Prospective evaluation of 300 asymptomatic women, ≥18 years old, with CBE, iBE, and mammography was performed. Sensitivity, specificity, positive predictive values (PPV), and negative predictive values (NPV) of iBE and CBE for detecting suspicious breast lesions were calculated using breast imaging as the reference standard. For women with one year follow up, the sensitivity, specificity, PPV, and NPV for cancer detection were calculated.Results: 300 women (mean age 58.9 years) underwent CBE, iBE, and mammography. In 2/300 (0.7%), CBE was positive; in 1/300 (0.3%), iBE was positive; and in 24/300 (8%), screening mammograms were positive. Nine had suspicious imaging findings with biopsy (three malignant and six benign). Of three cancers, all visualized mammographically, CBE and iBE detected an ipsilateral breast abnormality in one woman and missed two cancers (<2 cm). Sensitivity, specificity, NPV, and PPV of iBE and CBE were similar, with no statistically significant difference in NPV or PPV for detection of suspicious breast findings or breast cancer (p> 0.05).Conclusions: Mammography detected all breast cancers in our cohort and remains the standard of care. iBE is feasible to perform. Our pilot data demonstrates iBE performed similarly to CBE by trained nurse practitioners. Given our small study population, further investigation is warranted into the potential use of iBE where trained healthcare practitioners are not readily available.
背景/目的:iBE乳腺检查通过电子触诊方式识别可能的乳腺异常。本研究旨在评估iBE检查的可行性,并将其与临床乳腺检查在乳腺病灶检测方面进行比较。方法:对300名年龄≥18岁的无症状女性进行前瞻性评估,同步实施临床乳腺检查、iBE检查及乳腺X线摄影。以乳腺影像学检查结果为参照标准,计算iBE和临床乳腺检查在检测可疑乳腺病灶时的敏感性、特异性、阳性预测值及阴性预测值。对完成一年随访的女性,计算其癌症检测的敏感性、特异性、阳性预测值与阴性预测值。结果:300名女性(平均年龄58.9岁)接受了临床乳腺检查、iBE检查及乳腺X线摄影。其中临床乳腺检查阳性2例(0.7%),iBE检查阳性1例(0.3%),筛查性乳腺X线摄影阳性24例(8%)。9例存在可疑影像学表现者接受了活检(3例恶性,6例良性)。在3例癌症患者中,所有病灶均经乳腺X线摄影发现,临床乳腺检查与iBE检查仅在其中1例女性中检出同侧乳腺异常,漏诊了2例癌灶(<2厘米)。iBE与临床乳腺检查的敏感性、特异性、阴性预测值及阳性预测值相近,二者在可疑乳腺病变或乳腺癌检出方面的阴性预测值与阳性预测值均无统计学显著差异(p>0.05)。结论:在本研究队列中,乳腺X线摄影检测出了所有乳腺癌病例,仍是当前标准检查方法。iBE检查具有实施可行性。我们的初步数据表明,经培训的护理人员操作iBE检查的效果与临床乳腺检查相当。鉴于本研究样本量较小,未来有必要进一步探索iBE在缺乏训练有素的医疗从业人员环境中的潜在应用价值。