Department of Radiology, Campus Charité Virchow Klinikum, Berlin, Germany.
Invest Radiol. 2011 Nov;46(11):697-704. doi: 10.1097/RLI.0b013e318229ff25.
To evaluate the efficacy of the near-infrared (NIR) dye Omocianine in a placebo-controlled, dose-escalating multicenter trial for the detection of malignant breast lesions by using a NIR imaging system.
The study was approved by the ethical review board of Berlin and Münster,, and all participants provided written informed consent. Fifty-two consecutive patients were examined with NIR imaging before, during, and after intravenous injection of Omocianine. Three-dimensional absorption and fluorescence diffuse optical tomography scans were recorded simultaneously on a prototype NIR imaging unit (Computed Tomography Laser Mammography, Imaging Diagnostic Systems, Inc., Ft. Lauderdale, FL). Two readers assessed the images in consensus and assigned visibility scores to lesions seen on the absorption and absorption-corrected fluorescence diffuse optical tomography mammograms. Imaging results were compared with histopathologic findings. To analyze whether lesion detection rate for malignant lesions depended on the size of the lesion, lesions were dichotomized into those measuring less than 20 mm and those measuring 20 mm or more. Moreover, the shortest diameter between the center of the target lesions and the skin was measured on axial optical mammography data.
There were a total of 53 target lesions. Histopathologically, 22 target lesions were diagnosed as benign and 31 target lesions as malignant. In the absorption mode, a detection rate of 11.8% for benign and 44.4% for malignant lesions across all dose groups was found. In the fluorescence mode, a detection rate of 17.6% was revealed for benign and 55.6% for malignant lesions across all dose groups. For dose group 0.1 mg/kg, a detection rate of 100% was found for malignant lesions in the fluorescence mode and 71.4% in the absorption mode. Across all dose groups in the fluorescence mode, detection rate for malignant target lesions in breasts smaller than the median axial breast diameter of 12.8 cm was higher with 69.2% than in median diameters ≥ 12.8 cm with 46.2%. Omocianine-enhanced fluorescence optical mammography allowed a better detection of more superficially located lesions, with detection rates for a lesion-skin distance <20 mm of 63.6%, for <30 mm of 47.4% and for ≥ 30 mm of 25%. Malignant target lesions with a diameter ≥ 20 mm were slightly better detected with 61.5% in contrast to suspicious lesions <20 mm with 53.8%. Optimal imaging time points varied strongly among the different target lesions and Omocianine dose groups, with a mean optimal time point for malignant lesions at 188 ± 385 minutes.
Preliminary data suggest that fluorescence imaging after Omocianine administration has the potential to detect malignant breast lesions. As our study showed considerable variations in the detection of breast cancer at different fluorophore concentrations ranging from 20% to 100%, future work needs to be done to assess the suitable dose for NIR imaging.
使用近红外（NIR）成像系统，评估近红外染料奥米加菌素在安慰剂对照、剂量递增的多中心试验中检测恶性乳腺病变的疗效。
该研究得到柏林和明斯特伦理审查委员会的批准，所有参与者均提供了书面知情同意书。52 例连续患者在静脉注射奥米加菌素前后进行 NIR 成像检查。同时使用原型 NIR 成像设备（计算机断层激光乳腺成像系统，Imaging Diagnostic Systems，Inc.，佛罗里达州劳德代尔堡）记录三维吸收和荧光漫射光学断层扫描。两名读者在共识的基础上评估图像，并为吸收和吸收校正荧光漫射光学断层扫描乳腺图像上可见的病变分配可视性评分。成像结果与组织病理学结果进行比较。为了分析恶性病变的检出率是否取决于病变的大小，将病变分为小于 20mm 和 20mm 或更大的病变。此外，在轴向光学乳腺摄影数据上测量目标病变的中心与皮肤之间的最短直径。
共有 53 个目标病变。组织病理学检查显示，22 个目标病变诊断为良性，31 个目标病变诊断为恶性。在吸收模式下，所有剂量组的良性病变检出率为 11.8%，恶性病变检出率为 44.4%。在荧光模式下，所有剂量组的良性病变检出率为 17.6%，恶性病变检出率为 55.6%。对于 0.1mg/kg 剂量组，荧光模式下恶性病变的检出率为 100%，吸收模式下为 71.4%。在所有剂量组的荧光模式下，中位轴向乳房直径小于 12.8cm 的乳房中恶性靶病变的检出率为 69.2%，而中位直径大于或等于 12.8cm 的乳房为 46.2%。奥米加菌素增强荧光光乳腺摄影可以更好地检测到更表浅的病变，病变-皮肤距离小于 20mm 的检出率为 63.6%，小于 30mm 的检出率为 47.4%，大于或等于 30mm 的检出率为 25%。与可疑病变 <20mm 的 53.8%相比，直径≥20mm 的恶性靶病变的检出率略高，为 61.5%。
初步数据表明，奥米加菌素给药后荧光成像有可能检测到恶性乳腺病变。由于我们的研究显示，在不同的荧光团浓度（20%至 100%）下，乳腺癌的检测存在相当大的差异，因此需要进一步研究以评估适合 NIR 成像的剂量。
