Evaluation of novel approaches to early diagnosis of breast cancer by radiologic imaging with innovative high-resolution CT at low dose in direct comparison to the clinical gold standards digital mammography and MR

乳腺癌的早期诊断带来了重大挑战。尽管数字化乳房x光检查（DM）的引入以及系统的基于人群的筛查项目已经改善了乳腺癌的分期分布，并对乳腺癌死亡率产生了记录在案的影响，但似乎仍有改进的空间。人们一致认为，从2D投影成像到3D横断面成像的过渡将提供优势，这已经被磁共振（MR）断层成像的引入所证明。新的计算机断层扫描（CT）方法可以提供前所未有的3D空间分辨率（优于100 μ m），在低于5 mGy的极低剂量水平下，也就是说，符合筛查乳房x光检查的要求，这可能会带来类似甚至更大的进步。在欧盟（EU）、德国科学基金会（DFG）和德国研究与教育部（BMBF）资助的研究基础上，在过去五年中，在埃尔兰根开发了一种满足这些要求并提供动态扫描的设备。虽然已发表的研究结果是可用的，但临床试验研究仍然缺失。申请人的主要目标是系统地评估和评估高分辨率CT诊断乳腺癌的潜力。计划使用非增强和动态对比增强扫描进行基础实验和临床试点研究。新的CT方法应该直接与动态的、增强的MR进行比较，后者目前被认为是最有前途的，但成本很高的手术，也应该与数字化乳房x线摄影进行比较，后者是既定的临床标准。这些研究将通过两个密切协调的子项目进行：由W. Kalender协调的子项目1 （TP1）将侧重于优化图像质量和辐射剂量以及开发新的应用。双能CT探索和利用该扫描仪提供的光子计数、能量鉴别碲化镉探测器技术的特点具有特别重要的意义。子项目2 (TP2)，由C. Kuhl协调，将重点放在亚琛和埃尔兰根的临床试点研究和对结果的全面评估。我们提出的两个站点并行推进项目的构建，旨在让两个专家组参与其中，一个在乳腺CT领域领先，一个在乳腺MR领域领先，以确保高水平的相互控制和质疑。申请人声称乳房CT可以提供与MR相同或更高的诊断潜力，但具有更高的时间和空间分辨率以及精细的钙化显示。预计研究结果将在国际上引起高度的科学兴趣。它们还可能对卫生经济产生影响，并以比MR更低的成本提供更广泛的患者覆盖范围，与DM和BT相当。此外，CT将为患者提供更高的舒适度，无需压迫乳房，扫描时间缩短至2-10秒。

The early diagnosis of breast cancer poses significant challenges. Although the introduction of digital mammography (DM) together with systematic population-based screening programs has improved the stage distribution of breast cancer and has a documented impact on breast cancer mortality, there appears to be room for improvement. There is consensus that the transition from 2D projection imaging to 3D cross-sectional imaging will provide advantages as has been demonstrated already by the introduction of magnetic resonance (MR) tomography. Similar or even greater advances may be expected from novel computed tomography (CT) approaches that provide an unprecedented 3D spatial resolution (better than 100 µm) at very low dose levels of below 5 mGy, i.e., matching the requirements for screening mammography. A device fulfilling these requirements and offering dynamic scans has been developed in Erlangen during the past five years on the basis of research funded by the European Union (EU), the German science foundation (DFG) and the German ministry of research and education (BMBF). Although published results are available, clinical pilot studies are still missing.The main goal of the applicants is the systematic evaluation and assessment of the potential of high-resolution CT for diagnosis of breast cancer. Both basic experiments and clinical pilot studies using unenhanced and dynamic contrast-enhanced scanning are planned. The novel CT approach shall be compared directly with dynamic, contrast-enhanced MR, currently ranked as the most promising, yet costly procedure and also to digital mammography, the established clinical standard. These studies shall be carried out via two closely coordinated subprojects: subproject 1 (TP1), coordinated by W. Kalender, will focus on optimization of image quality and radiation dose and on the development of new applications. Approaches to dual-energy CT exploring and exploiting the features of the photon counting, energy discriminating cadmium telluride detector technology offered by the scanner are of special importance. Subproject 2 (TP2), coordinated by C. Kuhl, will focus on clinical pilot studies in Aachen und Erlangen and on the thorough evaluation of the results. The proposed construct of pushing a project in parallel at two sites aims at involving two expert groups, one leading in breast CT and one leading in breast MR, in order to ensure mutual control and questioning at a high level. The applicants claim that breast CT may offer the same or higher diagnostic potential as MR, but with higher temporal and spatial resolution and exquisite displays of calcifications. Results are expected to meet with very high scientific interest internationally. They may also have impact on health ecomomy and provide broad patient coverage at lower cost than MR and comparable to DM and BT. In addition CT will offer higher patient comfort without compression of the breast and short scan times of 2-10 seconds.