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

与临床金标准数字乳房X线摄影和MR直接比较，通过低剂量创新高分辨率CT放射成像来评估早期诊断乳腺癌的新方法

• 批准号: 242917389
• 负责人: Professor Dr. Willi A. Kalender
• 金额: --
• 依托单位: Klinik für Diagnostische und Interventionelle Radiologie
• 依托单位国家: 德国
• 项目类别: Research Grants
• 财政年份: 2014
• 资助国家: 德国
• 起止时间: 2013-12-31 至 2017-12-31
• 项目状态: 已结题
• 来源: https://gepris.dfg.de/gepris/projekt/242917389?language=en
• 关键词: Evaluation; novel; approaches; early; diagnosis

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.

乳腺癌的早期诊断带来了巨大的挑战。尽管数字化乳腺X线摄影（DM）的引入以及系统性的基于人群的筛查计划改善了乳腺癌的分期分布，并对乳腺癌死亡率产生了有记录的影响，但似乎还有改进的余地。已经达成共识的是，从2D投影成像到3D横截面成像的转变将提供如已经通过磁共振（MR）断层摄影术的引入所证明的优势。类似或甚至更大的进步可能来自新型计算机断层扫描（CT）方法，该方法在低于5 mGy的非常低的剂量水平下提供前所未有的3D空间分辨率（优于100 µm），即，符合筛查乳房X光检查的要求。在过去的五年中，在欧盟（EU）、德国科学基金会（DFG）和德国研究和教育部（BMBF）资助的研究基础上，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。虽然有发表的结果，但临床试点研究仍然缺失，申请人的主要目标是系统评价和评估高分辨率CT诊断乳腺癌的潜力。计划使用未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方法应直接与动态对比增强MR（目前被评为最有前途但成本最高的手术）以及数字乳腺X射线摄影（已确立的临床标准）进行比较。这些研究将通过两个密切协调的分项目进行：分项目1（TP 1），由W. Kalender将专注于图像质量和辐射剂量的优化以及新应用的开发。探索和利用双能CT扫描仪所提供的光子计数、能量鉴别碲化镉探测器技术的特点是双能CT的重要途径。次级项目2（TP 2），由C. Kuhl博士将专注于在亚琛和埃尔兰根进行的临床试点研究，并对结果进行全面评估。在两个研究中心并行推进一个项目的拟议结构旨在涉及两个专家组，一个领导乳腺CT，一个领导乳腺MR，以确保相互控制和高水平的提问。申请人声称，乳腺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钙化的精细显示。预计研究结果将在国际上引起很高的科学兴趣。它们还可能对健康经济产生影响，并以低于MR的成本提供广泛的患者覆盖，与DM和BT相当。此外，CT将提供更高的患者舒适度，而不会压迫乳房，扫描时间短至2-10秒。