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

根据目前的S3指南，新诊断乳腺癌分期患者的常规成像算法包括临床检查、X射线乳腺摄影、乳腺和腋窝超声、CT胸部/腹部扫描、乳腺MRI以确定局部切除边缘（仅在超声和乳房X线检查结果不清楚，或在组织学上浸润性小叶癌，高遗传风险以及年轻，该研究的主要目的是将S3-指南算法与FDG-PET/MRI进行比较，关于由于FDG PET/MRI扫描产生的附加信息而引起的乳房的治疗变化的相对频率。因此，研究的主要终点是局部治疗过程的变化。次要终点是全身FDG-PET/MRI结果导致的所有其他治疗变化。此外，将比较S3指南算法、全身MRI、全身FDG-PET和全身FDG-PET/MRI在T、N和M分期和UICC分类的诊断准确性（灵敏度、特异性、阳性预测值、阴性预测值、准确性）方面的差异。

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.