多模态缺氧成像联合调强放疗不可切除性非小细胞肺癌：HIL 试验。
Multimodal hypoxia imaging and intensity modulated radiation therapy for unresectable non-small-cell lung cancer: the HIL trial.
机构信息
Department of Radiation Oncology, University of Heidelberg, INF 400, 69120, Heidelberg, Germany.
出版信息
Radiat Oncol. 2012 Sep 14;7:157. doi: 10.1186/1748-717X-7-157.
BACKGROUND
Radiotherapy, preferably combined with chemotherapy, is the treatment standard for locally advanced, unresectable non-small cell lung cancer (NSCLC). The tumor response to different therapy protocols is variable, with hypoxia known to be a major factor that negatively influences treatment effectiveness. Visualisation of tumor hypoxia prior to the use of modern radiation therapy strategies, such as intensity modulated radiation therapy (IMRT), might allow optimized dose applications to the target volume, leading to improvement of therapy outcome. (18)F-fluoromisonidazole dynamic positron emission tomography and computed tomography ((18) F-FMISO dPET-CT) and functional magnetic resonance imaging (functional MRI) are attractive options for imaging tumor hypoxia.
METHODS/DESIGN: The HIL trial is a single centre study combining multimodal hypoxia imaging with (18) F-FMISO dPET-CT and functional MRI, with intensity modulated radiation therapy (IMRT) in patients with inoperable stage III NSCLC. 15 patients will be recruited in the study. All patients undergo initial FDG PET-CT and serial (18) F-FMISO dPET-CT and functional MRI before treatment, at week 5 of radiotherapy and 6 weeks post treatment. Radiation therapy is performed as inversely planned IMRT based on 4D-CT.
DISCUSSION
Primary objectives of the trial are to characterize the correlation of (18) F-FMISO dPET-CT and functional MRI for tumor hypoxia imaging in NSCLC and evaluate possible effects of radiation therapy on tumor re-oxygenation. Further objectives include the generation of data regarding the prognostic value of (18) F-FMISO dPET-CT and functional MRI for locoregional control, progression free survival and overall survival of NSCLC treated with IMRT, which will form the basis for larger clinical trials focusing on possible interactions between tumor oxygenation and radiotherapy outcome.
TRIAL REGISTRATION
The ClinicalTrials.gov protocol ID is NCT01617980.
背景
放射治疗，最好联合化疗，是局部晚期、不可切除的非小细胞肺癌（NSCLC）的治疗标准。不同治疗方案的肿瘤反应是可变的，已知缺氧是一个主要的负面因素，影响治疗效果。在使用现代放射治疗策略（如调强放射治疗（IMRT））之前，对肿瘤缺氧进行可视化，可能允许对靶区进行优化剂量应用，从而改善治疗效果。（18）F-氟米索硝唑动态正电子发射断层扫描和计算机断层扫描（（18）F-FMISO dPET-CT）和功能磁共振成像（功能 MRI）是用于成像肿瘤缺氧的有吸引力的选择。
方法/设计：HIL 试验是一项单中心研究，将多模态缺氧成像与（18）F-FMISO dPET-CT 和功能 MRI 相结合，对不可切除的 III 期 NSCLC 患者进行调强放射治疗（IMRT）。该研究将招募 15 名患者。所有患者在治疗前、放射治疗第 5 周和治疗后 6 周进行初始 FDG PET-CT 和连续（18）F-FMISO dPET-CT 和功能 MRI。放射治疗是根据 4D-CT 进行逆向计划的 IMRT。
讨论
该试验的主要目标是描述（18）F-FMISO dPET-CT 和功能 MRI 对 NSCLC 肿瘤缺氧成像的相关性，并评估放射治疗对肿瘤再氧合的可能影响。进一步的目标包括生成关于（18）F-FMISO dPET-CT 和功能 MRI 对 IMRT 治疗 NSCLC 的局部控制、无进展生存期和总生存期的预后价值的数据，这将为关注肿瘤氧合与放射治疗结果之间可能相互作用的更大临床试验提供基础。
试验注册
ClinicalTrials.gov 方案 ID 为 NCT01617980。
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