Department of Radiation Oncology, University Hospital of Heidelberg, Germany.
BMC Cancer. 2012 Apr 3;12:133. doi: 10.1186/1471-2407-12-133.
The purpose of this clinical study is to investigate the clinical feasibility and effectiveness of offline Positron-Emission-Tomography (PET) quality assurance for promoting the accuracy of proton and carbon ion beam therapy.
METHODS/DESIGN: A total of 240 patients will be recruited, evenly sampled among different analysis groups including tumors of the brain, skull base, head and neck region, upper gastrointestinal tract including the liver, lower gastrointestinal tract, prostate and pelvic region. From the comparison of the measured activity with the planned dose and its corresponding simulated activity distribution, conclusions on the delivered treatment will be inferred and, in case of significant deviations, correction strategies will be elaborated.
The investigated patients are expected to benefit from this study, since in case of detected deviations between planned and actual treatment delivery a proper intervention (e.g., correction) could be performed in a subsequent irradiation fraction. In this way, an overall better treatment could be achieved than without any in-vivo verification. Moreover, site-specific patient-population information on the precision of the ion range at HIT might enable improvement of the CT-range calibration curve as well as safe reduction of the treatment margins to promote enhanced treatment plan conformality and dose escalation for full clinical exploitation of the promises of ion beam therapy.
NCT01528670.
本临床研究旨在探讨离线正电子发射断层扫描（PET）质量保证在提高质子和碳离子束治疗准确性方面的临床可行性和有效性。
方法/设计：将招募 240 名患者，平均分配到包括脑肿瘤、颅底、头颈部、上胃肠道（包括肝脏）、下胃肠道、前列腺和骨盆区域在内的不同分析组中。通过将测量的活性与计划剂量及其相应的模拟活性分布进行比较，可以推断出对所提供治疗的结论，如果存在明显偏差，则制定纠正策略。
预期研究中的患者将从中受益，因为如果在计划和实际治疗输送之间检测到偏差，可以在下一次照射部分中进行适当的干预（例如纠正）。这样，就可以实现比没有任何体内验证更好的整体治疗效果。此外，HIT 处离子射程精度的特定部位患者人群信息可以改进 CT 射程校准曲线，并安全减少治疗边界，以促进治疗计划的一致性和剂量升级，从而充分利用离子束治疗的承诺。
NCT01528670。
