Our rationale was to investigate whether ¹⁸F-FDG PET/MRI in addition to (guideline-recommended) conventional staging leads to changes in therapeutic management in patients with newly diagnosed breast cancer and compare the diagnostic accuracy of ¹⁸F-FDG PET/MRI with that of conventional staging for determining the Union for International Cancer Control (UICC) stage. Methods: In this prospective, double-center study, 208 women with newly diagnosed, therapy-naïve invasive breast cancer were enrolled in accordance with the inclusion criteria. All patients underwent guideline-recommended conventional staging and whole-body ¹⁸F-FDG PET/MRI with a dedicated breast examination. A multidisciplinary tumor board served to determine 2 different therapy recommendations for each patient, one based on conventional staging alone and another based on combined assessment of conventional staging and ¹⁸F-FDG PET/MRI examinations. Major changes in therapy recommendations and differences between the conventional staging algorithm and ¹⁸F-FDG PET/MRI for determining the correct UICC stage were reported and evaluated. Results: Major changes in therapeutic management based on combined assessment of conventional staging and ¹⁸F-FDG PET/MRI were detected in 5 of 208 patients, amounting to changes in therapeutic management in 2.4% (95% CI, 0.78%–5.2%) of the study population. In determining the UICC stage, the guideline-based staging algorithm and ¹⁸F-FDG PET/MRI were concordant in 135 of 208 (64.9%; 95% CI, 58%–71.4%) patients. The conventional guideline algorithm correctly determined the UICC stage in 130 of 208 (62.5%; 95% CI, 55.5%–69.1%) patients, and ¹⁸F-FDG PET/MRI correctly determined the UICC stage in 170 of 208 (81.9%; 95% CI, 75.8%–86.7%) patients. Conclusion: Despite the diagnostic superiority of ¹⁸F-FDG PET/MRI over conventional staging in determining the correct UICC stage, the current (guideline-recommended) conventional staging algorithm is sufficient for adequate therapeutic management of patients with newly diagnosed breast cancer, and ¹⁸F-FDG PET/MRI does not have an impact on patient management.

我们的基本原理是调查 ¹⁸F-FDG PET/MRI 除了（指南推荐的）常规分期是否会导致新诊断乳腺癌患者治疗管理的变化，并将 ¹⁸F-FDG PET/MRI 的诊断准确性与常规分期的诊断准确性进行比较确定国际癌症控制联盟 （UICC） 分期。方法：在这项前瞻性双中心研究中，根据纳入标准招募了 208 名新诊断的初治浸润性乳腺癌女性。所有患者均接受指南推荐的常规分期和全身 ¹⁸F-FDG PET/MRI 和专门的乳房检查。一个多学科肿瘤委员会用于为每位患者确定 2 种不同的治疗建议，一种基于单独的常规分期，另一种基于常规分期和 ¹⁸次 F-FDG PET/MRI 检查的组合评估。报告和评估了治疗推荐的主要变化以及常规分期算法与 ¹⁸F-FDG PET/MRI 在确定正确 UICC 分期方面的差异。结果：根据常规分期和 ¹⁸F-FDG PET/MRI 的联合评估，在 208 名患者中的 5 名中检测到治疗管理的重大变化，相当于 2.4% （95% CI，0.78%-5.2%） 的研究人群的治疗管理发生变化。在确定 UICC 分期时，208 例患者中有 ¹³⁵例 （64.9%;95% CI，58%-71.4%） 的基于指南的分期算法和 18 例 F-FDG PET/MRI 一致。常规指南算法正确确定了 208 例中的 130 例 （62.5%;95% CI，55.5%–69.1%）患者，¹⁸例 F-FDG PET/MRI 正确确定了 208 例患者中 170 例 （81.9%;95% CI，75.8%–86.7%） 患者的 UICC 分期。结论：尽管 ¹⁸F-FDG PET/MRI 在确定正确的 UICC 分期方面优于传统分期，但当前（指南推荐的）常规分期算法足以对新诊断的乳腺癌患者进行充分的治疗管理，并且 ¹⁸F-FDG PET/MRI 对患者管理没有影响。