Hybrid MR-PET for whole-body staging in breast cancer

根据现行的S3指南，新诊断乳腺癌患者分期的常规影像学算法包括临床检查、x线乳房x线摄影、乳房和腋窝超声、CT胸/腹扫描、乳房MRI以确定局部切除边缘（仅在超声和乳房x线摄影未明确发现，或在组织学浸润性小叶癌、高遗传风险以及年轻、绝经前患者中），以及骨骼闪烁成像。本研究的主要目的是比较s3指南算法与FDG-PET/MRI关于由于FDG PET/MRI扫描产生的额外信息而导致乳房治疗改变的相对频率。因此，研究的主要终点是局部治疗过程的改变。次要终点是由于全身FDG-PET/MRI结果而导致的所有其他治疗变化。此外，比较S3-guidelines算法、全身MRI、全身FDG-PET和全身FDG-PET/MRI对T、N、M分期和UICC分类的诊断准确性（敏感性、特异性、阳性预测值、阴性预测值、准确性）。

According to the current S3 guideline, the conventional imaging algorithm for the staging patients with newly diagnosed breast cancer includes clinical examination, X-ray mammography, breast and axillary ultrasound, a CT thorax / abdomen scan, MRI of the breast to determine local excision margins (only in ultrasound and mammography unclear findings, or in histologically invasive lobular carcinoma, high genetic risk as well as young, premenopausal patients), as well as skeletal scintigraphy.The primary objective of the study is to compare the S3-guideline algorithm to FDG-PET/MRI concerning the relative frequency of therapy changes of the breast due to additional information arising from the FDG PET/MRI scan. Thus, the primary endpoint of the study is the change in the local therapy process. Secondary endpoints are all other therapy changes as a result of whole body FDG-PET/MRI findings. In addition, a comparison of the S3-guidelines algorithm, whole-body MRI, whole-body FDG-PET and whole-body FDG-PET/MRI in terms of diagnostic accuracy (sensitivity, specificity, positive predictive value, negative predictive value, accuracy) for the T, N and M staging and the UICC classification will be performed.