Memorial Sloan Kettering Cancer Center, 1275 York Ave., New York, NY 10065, USA; Department of Radiology, Breast Imaging Service, Memorial Sloan Kettering Cancer Center, New York, USA.
Memorial Sloan Kettering Cancer Center, 1275 York Ave., New York, NY 10065, USA; Department of Radiology, Breast Imaging Service, Memorial Sloan Kettering Cancer Center, New York, USA; Department of Biomedical Imaging and Image-guided Therapy, Division of Molecular and Gender Imaging, Medical University of Vienna, Vienna, Austria.
Eur J Radiol. 2017 Dec;97:37-43. doi: 10.1016/j.ejrad.2017.10.001. Epub 2017 Oct 7.
Contrast enhanced digital mammography (CEDM) is a new breast imaging technology increasingly used in the diagnostic setting but its utility in the pure screening setting has not been reported. The goal of this pilot study is to prospectively compare screening CEDM to breast MRI in women with an increased risk for breast cancer.
In this IRB-approved HIPAA-compliant study, 318 women at increased breast cancer risk were consented (December 2012-May 2015) to undergo CEDM in addition to their scheduled MRI. CEDM was performed within 30days of screening MRI. CEDM was interpreted blinded to MRI. The reference standard was defined as a combination of pathology and 2-year imaging follow-up.
Data from 307/318 patients were evaluable. Three cancers (two invasive cancers, one ductal carcinoma in situ) were detected at first round screening: MRI detected all three and CEDM detected the two invasive cancers. None of the three cancers was seen on the low energy mammograms which are comparable to conventional mammography. At 2year imaging follow up, there were 5 additional screen detected cancers and no palpable cancers. The positive predictive value 3 (PPV) for CEDM was 15% (2/13, 95% CI: 2-45%) and 14% for MRI (3/21, 95% CI: 3-36%). The specificity of CEDM and MRI were 94.7% and 94.1% respectively.
Both CEDM and MRI detected additional cancers not seen on conventional mammography, primarily invasive cancers. Our pilot data suggest that CEDM could be valuable as a supplemental imaging exam for women at increased risk for breast cancer who do not meet the criteria for MRI or for whom access to MRI is limited. Validation in larger multi institutional trials is warranted.
对比增强数字乳腺摄影术（CEDM）是一种新的乳腺成像技术，在诊断中越来越多地使用，但在单纯的筛查环境中的应用尚未报道。本研究的目的是前瞻性地比较筛查 CEDM 与乳腺 MRI 在乳腺癌高危女性中的应用。
本研究经机构审查委员会批准，符合 HIPAA 标准，共纳入 318 名乳腺癌高危女性（2012 年 12 月至 2015 年 5 月），这些女性除了接受常规 MRI 检查外，还接受了 CEDM 筛查。CEDM 在筛查性 MRI 后 30 天内进行。CEDM 的解读是盲法的，不参考 MRI 结果。参考标准定义为病理学和 2 年影像学随访的结合。
307/318 名患者的数据可评估。第一轮筛查发现了 3 例癌症（2 例浸润性癌，1 例导管原位癌）：MRI 检测到了所有 3 例，而 CEDM 检测到了 2 例浸润性癌。这 3 例癌症在低能量乳腺 X 线摄影中均未见，而低能量乳腺 X 线摄影类似于传统的乳腺 X 线摄影。在 2 年的影像学随访中，又发现了 5 例筛查发现的癌症，没有可触及的癌症。CEDM 的阳性预测值（PPV）为 15%（2/13，95%CI：2-45%），MRI 的 PPV 为 14%（3/21，95%CI：3-36%）。CEDM 和 MRI 的特异性分别为 94.7%和 94.1%。
CEDM 和 MRI 都发现了传统乳腺 X 线摄影术未发现的额外癌症，主要是浸润性癌症。我们的初步数据表明，CEDM 可能对不符合 MRI 标准或 MRI 检查受限的乳腺癌高危女性有价值，可作为补充性影像学检查手段。需要在更大的多机构试验中进行验证。
