Department of Radiology, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Department of Translational Medicine, Lund University, Malmö, Sweden.
Med Phys. 2022 Apr;49(4):2220-2232. doi: 10.1002/mp.15553. Epub 2022 Mar 4.
Virtual clinical trials (VCTs) require computer simulations of representative patients and images to evaluate and compare changes in performance of imaging technologies. The simulated images are usually interpreted by model observers whose performance depends upon the selection of imaging cases used in training evaluation models. This work proposes an efficient method to simulate and calibrate soft tissue lesions, which matches the detectability threshold of virtual and human readings.
Anthropomorphic breast phantoms were used to evaluate the simulation of four mass models (I-IV) that vary in shape and composition of soft tissue. Ellipsoidal (I) and spiculated (II-IV) masses were simulated using composite voxels with partial volumes. Digital breast tomosynthesis projections and reconstructions of a clinical system were simulated. Channelized Hotelling observers (CHOs) were evaluated using reconstructed slices of masses that varied in shape, composition, and density of surrounded tissue. The detectability threshold of each mass model was evaluated using receiver operating characteristic (ROC) curves calculated with the CHO's scores.
The area under the curve (AUC) of each calibrated mass model were within the 95% confidence interval (mean AUC [95% CI]) reported in a previous reader study (0.93 [0.89, 0.97]). The mean AUC [95% CI] obtained were 0.94 [0.93, 0.96], 0.92 [0.90, 0.93], 0.92 [0.90, 0.94], 0.93 [0.92, 0.95] for models I to IV, respectively. The mean AUC results varied substantially as a function of shape, composition, and density of surrounded tissue.
For successful VCTs, lesions composed of soft tissue should be calibrated to simulate imaging cases that match the case difficulty predicted by human readers. Lesion composition, shape, and size are parameters that should be carefully selected to calibrate VCTs.
虚拟临床试验(VCT)需要对具有代表性的患者和图像进行计算机模拟,以评估和比较成像技术性能的变化。模拟图像通常由模型观察者进行解释,其性能取决于用于训练评估模型的成像病例的选择。这项工作提出了一种有效的方法来模拟和校准软组织病变,使其与虚拟和人工读数的检测阈值相匹配。
使用人体乳房模型来评估四种质量模型(I-IV)的模拟,这些模型在软组织的形状和组成上有所不同。使用具有部分体积的复合体素模拟了椭圆形(I)和有刺状突起的(II-IV)肿块。模拟了临床系统的数字乳腺断层合成投影和重建。使用形状、组成和周围组织密度不同的肿块重建切片评估通道化霍特林观察者(CHO)。使用 CHO 评分计算的接收器操作特征(ROC)曲线评估每个肿块模型的检测阈值。
每个校准质量模型的曲线下面积(AUC)都在之前的读者研究报告的 95%置信区间(平均 AUC [95%CI])内(0.93 [0.89, 0.97])。分别获得的平均 AUC [95%CI] 为 0.94 [0.93, 0.96]、0.92 [0.90, 0.93]、0.92 [0.90, 0.94]和 0.93 [0.92, 0.95],分别用于模型 I 至 IV。平均 AUC 结果随着周围组织的形状、组成和密度的变化而大幅变化。
为了成功进行 VCT,应校准由软组织组成的病变,以模拟与人类读者预测的病例难度相匹配的成像病例。病变的组成、形状和大小是需要仔细选择的 VCT 校准参数。