Mastanduno Michael A, Xu Junqing, El-Ghussein Fadi, Jiang Shudong, Yin Hong, Zhao Yan, Wang Ke, Ren Fang, Gui Jiang, Pogue Brian W, Paulsen Keith D
Thayer School of Engineering, Dartmouth College, Hanover, New Hampshire.
Department of Radiology, Xijing Hospital, Xi'an, China.
Clin Cancer Res. 2015 Sep 1;21(17):3906-12. doi: 10.1158/1078-0432.CCR-14-2546. Epub 2015 May 27.
The purpose of this study was to determine the diagnostically most important molecular biomarkers quantified by magnetic resonance-guided (MR) near-infrared spectral tomography (NIRST) that distinguish malignant breast lesions from benign abnormalities when combined with outcomes from clinical breast MRI.
The study was HIPAA compliant and approved by the Dartmouth Institutional Review Board, the NIH, the United States State Department, and Xijing Hospital. MR-guided NIRST evaluated hemoglobin, water, and lipid content in regions of interest defined by concurrent dynamic contrast-enhanced MRI (DCE-MRI) in the breast. MRI plus NIRST was performed in 44 subjects (median age, 46, age range, 20-81 years), 28 of whom had subsequent malignant pathologic diagnoses, and 16 had benign conditions. A subset of 30 subject examinations yielded optical data that met minimum sensitivity requirements to the suspicious lesion and were included in the analyses of diagnostic performance.
In the subset of 30 subject examinations meeting minimum optical data sensitivity criterion, the MR-guided NIRST separated malignant from benign lesions using total hemoglobin (HbT; P < 0.01) and tissue optical index (TOI; P < 0.001). Combined MRI plus TOI data caused one false positive and 1 false negative, and produced the best diagnostic performance, yielding an AUC of 0.95, sensitivity of 95%, specificity of 89%, positive predictive value of 95%, and negative predictive value of 89%, respectively.
MRI plus NIRST results correlated well with histopathologic diagnoses and could provide additional information to reduce the number of MRI-directed biopsies.
本研究的目的是确定通过磁共振引导（MR）近红外光谱断层扫描（NIRST）定量的诊断最重要的分子生物标志物，当与临床乳腺MRI结果相结合时，这些标志物可区分恶性乳腺病变与良性异常。
该研究符合健康保险流通与责任法案（HIPAA），并获得达特茅斯机构审查委员会、美国国立卫生研究院、美国国务院和西京医院的批准。MR引导的NIRST评估了乳腺中由同步动态对比增强MRI（DCE-MRI）定义的感兴趣区域中的血红蛋白、水和脂质含量。对44名受试者（中位年龄46岁，年龄范围20 - 81岁）进行了MRI加NIRST检查，其中28人随后被诊断为恶性病理，16人患有良性疾病。30名受试者检查的一个子集产生了满足对可疑病变最低敏感度要求的光学数据，并被纳入诊断性能分析。
在满足最低光学数据敏感度标准的30名受试者检查子集中，MR引导的NIRST使用总血红蛋白（HbT；P < 0.01）和组织光学指数（TOI；P < 0.001）将恶性病变与良性病变区分开来。MRI加TOI数据导致1例假阳性和1例假阴性，并产生了最佳诊断性能，曲线下面积（AUC）为0.95，敏感度为95%，特异度为89%，阳性预测值为95%，阴性预测值为89%。
MRI加NIRST结果与组织病理学诊断相关性良好，并可为减少MRI引导活检的数量提供额外信息。
