Diagnosis of IM Nodal Metastases in Breast Cancer

描述（来自申请人摘要的逐字记录）：两个最近随机化的 前瞻性研究，包括不列颠哥伦比亚省（BC）癌症研究 机构，已经表明，辅助照射胸壁和淋巴结床 引流乳腺可提高生存率，即使在只有1-3个乳腺癌的患者中， 腋窝淋巴结转移。虽然这种方法包括治疗， 内乳淋巴结（IMN）链，IMN照射的重要性是 未知，并在术后放疗中纳入IMN放疗 仍然存在争议。这是因为（1）只有一个子集 作为辅助淋巴结床放疗候选者的患者实际上 IMN转移和（2）IMN放疗携带潜在的心脏，肺， 纵隔毒性目前的临床实践不包括IMN活检， 部分原因是由于无向IMN采样的发病率。FDG PET是一种非侵入性 腋窝淋巴结转移的高灵敏度的成像方法。我们 初步研究表明，它在检测IMN方面具有高度准确性， 也有转移。我们最近的工作也表明，淋巴映射与 病灶周围注射和淋巴管造影可以确定哪些肿瘤引流 到IMN。我们假设IMN转移诊断的逐步方法 使用FDG PET来识别大转移，使用淋巴结造影来识别 IMN引流可以选择患者进行IMN活检和放射治疗。一旦 验证了这种方法可以合理选择患者进行IMN放射治疗 并且仅在一部分患者中需要IMN活检。我们提出了一个 诊断研究，这将是一个联合项目，华盛顿大学 和BC癌症机构作为一个既定的合作的延伸。在 本研究将（1）开发FDG PET和淋巴结造影在 识别IMN转移，（2）识别预测较高的肿瘤特征， IMN转移的风险，以及（3）开发使用FDG PET的方法，以帮助计划 放疗这项诊断研究将提供重要数据， 未来的乳房内放疗试验。

DESCRIPTION (Verbatim from the Applicant's Abstract): Two recent randomized prospective studies, including a study at the British Columbia (BC) Cancer Agency, have shown that adjuvant irradiation of the chest wall and nodal beds draining the breast improves survival, even in patients with as few as 1-3 axillary Iymph node metastases. Although this approach included treatment to the internal mammary nodal (IMN) chain, the importance of IMN irradiation is unknown, and the inclusion of IMN radiotherapy in post-surgical radiotherapy remain controversial. This is due to the fact that (1) only a subset of patients who are candidates for adjuvant nodal bed radiotherapy actually have IMN metastases and (2) IMN radiotherapy carries potential cardiac, lung, and mediastinal toxicity. Current clinical practice does not include IMN biopsy, in part due to the morbidity of undirected IMN sampling. FDG PET is a non-invasive imaging method with high sensitivity for axillary lymph node metastases. Our preliminary studies suggest that it is highly accurate in detecting IMN metastases as well. Our recent work has also shown that lymphatic mapping with peri-lesional injection and lymphoscintigraphy can determine which tumors drain to the IMN. We hypothesize that a stepwise approach to IMN metastasis diagnosis using FDG PET to identify macrometastases and lymphoscintigraphy to identify drainage to the IMN can select patients for IMN biopsy and radiotherapy. Once validated this approach would rationally select patients for IMN radiation therapy and would require IMN biopsy in only a subset of patients. We propose a diagnostic study which will be a joint project between University of Washington and the BC Cancer Agency as an extension of an established collaboration. In this study we will (1) develop the role of FDG PET and lymphoscintigraphy in identifying IMN metastases, (2) identify tumor features that predict a higher risk for IMN metastases, and (3) develop methods for using FDG PET to help plan radiotherapy. This diagnostic study will provide important data to direct future internal mammary radiotherapy trials.