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Evaluation of a Pneumotachograph (SPI) for the Production of PET and CT Acquisitions Synchronized With Breath for the Assessment of Extension of Lung Cancer (SPI COHERENCE)

2014年10月8日 更新者:Institut Claudius Regaud
This is a pilot study, single-center, prospective, open-label, to assess the acceptability and performance of the experimental medical device (SPI) used during an imaging examination (PET / CT 4D imaging in synchronized mode centered on the thorax). Each patient will be its own control, since the imaging examination will be synchronized simultaneously with the two systems: tested Medical Device (SPI) and reference Medical Device(RPM).

研究概览

研究类型

介入性

注册 (实际的)

46

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

      • Toulouse、法国、31052
        • Institut Claudius Regaud

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:

  1. Patient for whom there is an indication of PET/CT 18FDG imaging for thoracic oncology ; this indication is consistent with the Standard Options Recommendations or was validated during Multidisciplinary Consultation Meeting :

    • Either an extension assessment of non-small cell lung cancer;
    • Either the characterization of single pulmonary nodule; Or - the definition of the target volume in radiotherapy.
  2. Patient who meets the following criteria to be eligible for an PET/CT imaging:

    • Patient able to maintain a supine position for 60 minutes
    • Patient with no bronchopulmonary infection and with no upper aero digestive tract acute infection in progress (increased risk of false positives)
  3. Age ≥ 18 years
  4. WHO ≤ 1
  5. Well-informed written consent signed by the patient and collected before any specific procedure in the study
  6. Patient member in a national insurance scheme

Exclusion Criteria:

  1. Patient with a bronchial carcinoid or bronchoalveolar cancer
  2. Patient with acute bronchopneumopathy
  3. Not stabilized diabetic patient
  4. Patient with an absolute indication against spirometry: ongoing pneumothorax or within the previous month, pleural biopsy or puncture within the previous month, hemoptysis, severe asthma, tuberculosis
  5. Any usual relative indication against spirometry: ongoing bronchial infections, acute asthma, decompensation of chronic respiratory failure, respiratory pain
  6. Any usual formal indication against imaging examination PET/CT (important claustrophobia)
  7. Patient unable to follow study procedures
  8. Pregnant women or nursing mothers can not participate in the study
  9. Men and women of childbearing age must use effective contraception at study entry and throughout the study
  10. Any other medical conditions making the inclusion of the patient in the study inappropriate in the opinion of the investigator
  11. Patient under legal guardianship

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:诊断
  • 分配:非随机化
  • 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:SPI Medical device
SPI medical device used during PET/CT 4D imaging in a synchronized mode centered on the thorax.
有源比较器:reference medical device : RPM
Reference medical device (RPM) used simultaneously during PET/CT 4D imaging in a synchronized mode centered on the thorax.

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
Feasibility of the PET/CT synchronized exam with SPI device ("success" or "failure" )
大体时间:2 years

feasibility is evaluated in a composite end point (success will be obtained in case of concomitant success of the 4 sub-criteria assessment):

  1. Tolerance / acceptability of the patient to breathe into SPI throughout the examination)
  2. Detection of breath cycle of the patient by measuring dCycleSpi (dCycleSpi = Number of synchronization signals emitted by SPI / total number of breath cycle * 100).
  3. Accuracy of detection of inspiratory peak amplitudes with SPI medical device: by measuring dtSpi (dtSpi = standard deviation of the time lag between synchronization signals and maximum inspiratory amplitude for each cycle).
  4. Production of images with a correct segmentation of BTV during PET/CT synchronized exam with SPI device"
2 years

次要结果测量

结果测量
措施说明
大体时间
Measure of dCycleRpm (dCycleRpmi = Number of synchronization signals emitted by RPM / total number of breath cycle * 100)
大体时间:2 years
2 years
Accuracy of detection of maximum inspiratory amplitudes with RPM medical device: evaluated by measuring dtRpm
大体时间:2 years
dtRpm = standard deviation of the time lag between synchronization signals and maximum inspiratory amplitude for each cycle
2 years
Measure of BTVrpm (= biologic tumoral volume)
大体时间:2 years
2 years

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:Frederic COURBON, PhD、Institut Claudius Regaud

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

2013年5月1日

初级完成 (实际的)

2014年9月1日

研究完成 (实际的)

2014年9月1日

研究注册日期

首次提交

2012年10月12日

首先提交符合 QC 标准的

2012年10月31日

首次发布 (估计)

2012年11月2日

研究记录更新

最后更新发布 (估计)

2014年10月9日

上次提交的符合 QC 标准的更新

2014年10月8日

最后验证

2014年9月1日

更多信息

与本研究相关的术语

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.

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