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DE-CT in Lung Cancer Proton Therapy (DE-CT)

2017年4月13日 更新者:Maastricht Radiation Oncology

DE-CT vs. SE-CT as Optimal Imaging During Treatment for Adaptive Proton Therapy in Stage III Non Small Cell Lung Cancer (NSCLC)

Dose distribution calculations for proton therapy are more accurate when based on DE-CT than on SE-CT. It is however unclear what the quantitative benefit of repeated DE-CT calculations is for lung cancer patients.

研究概览

地位

撤销

详细说明

In order to calculate the dose distribution of protons adequately, accurate estimations of the stopping power ratio (SPR) medium to water, are required. Using a conversion from single energy CT (SE-CT) images results in an uncertainty in the SPR of at least 3-4%. This uncertainty results in in the use of larger margins around the clinical target volume (CTV) and hence more dose to the organs at risk (OAR). It also effects in the conservative use of beam directions, which are often sub-optimal, to avoid irradiating normal tissues.

Dual energy CT (DE-CT) improves the accuracy of the SPR and therefore the proton range estimation.

An evaluation of the proton range for several tissues using SE-CT and DE-CT as input to Monte Carlo (MC) simulations showed on average improvements in range prediction from 0.1% to 2.1% when using DECT instead of SECT, but in several phantoms and also versus proton-CT, the errors on SE-CT based proton stopping power ratios are reported to be more than 7 %.

A limitation of these studies is that most of them were performed in phantoms. In the first clinical data set on five patients with base of skull tumours, it was reported that although the SPR estimation was indeed better for DE-CT than for SE-CT, its clinical relevance was unclear. However, in the same study, phantom measurements showed a large uncertainty of the SPR in the lung. This is due to the large heterogeneity of the lungs and the huge difference in the density of the lungs compared to the mediastinum, the tumour and the chest cavity.

It is therefore important to study the SPR differences of SE-CT compared to DE-CT in lung cancer patients and the impact on the dose distribution especially in the context of adaptive radiotherapy. As during the course of concurrent chemotherapy and radiotherapy, which is the standard treatment in the majority of stage III lung cancer patients, important anatomical changes may occur, it is also of clinical relevance to determine the influence of repeated dose calculations on DE-CT.

研究类型

介入性

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Limburg
      • Maastricht、Limburg、荷兰、6229 ET
        • Maastro clinic

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Histologically or cytologically confirmed locally advanced stage IIIA or III B (T0-4 N2-3M0) NSCLC, or M1 oligometastatic disease according to 7th TNM classification.
  • Scheduled to receive concurrent chemotherapy and radiotherapy to a dose of at least 60 Gy, as decided at the multidisciplinary tumour board
  • Able to give written informed consent
  • Able to have adequate contraception in woman with child bearing potential

Exclusion Criteria:

  • Not able to give written informed consent
  • Not able to comply with adequate contraception in woman with child bearing potential

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:其他
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Scans
Patients included in the trial will receive DE-CT in stead of SE-CT's.
Patients included in the trial will receive 3 extra DE-CT's and 3 extra SE-CT's

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Dose distribution on the CTV (measured in Gy)
大体时间:Measured during 2nd and 4th week of radiation treatment
Dose distribution on the CTV (clinical target volume) of the tumour and the lymph nodes of DE-CT vs. SE-CT
Measured during 2nd and 4th week of radiation treatment
Dose distribution on the OAR (measured in Gy)
大体时间:Measured during 2nd and 4th week of radiation treatment
Dose distribution on the OAR (organs at risk), lungs, heart, aorta, pulmonary artery, superior vena cava, oesophagus, spinal cord, vertebral body, of DE-CT vs. SE-CT
Measured during 2nd and 4th week of radiation treatment

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Dirk De Ruysscher, MD, PhD、Maastro Clinic, The Netherlands

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2016年9月1日

初级完成 (预期的)

2017年9月1日

研究完成 (预期的)

2017年12月1日

研究注册日期

首次提交

2016年7月19日

首先提交符合 QC 标准的

2016年7月21日

首次发布 (估计)

2016年7月26日

研究记录更新

最后更新发布 (实际的)

2017年4月14日

上次提交的符合 QC 标准的更新

2017年4月13日

最后验证

2016年8月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

DE-CT's and SE-CT的临床试验

3
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