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

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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.