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)
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
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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-
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Toulouse、法国、31052
- Institut Claudius REGAUD
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
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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.
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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)
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Age ≥ 18 years
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WHO ≤ 1
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Well-informed written consent signed by the patient and collected before any specific procedure in the study
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Patient member in a national insurance scheme
Exclusion Criteria:
- Patient with a bronchial carcinoid or bronchoalveolar cancer
- Patient with acute bronchopneumopathy
- Not stabilized diabetic patient
- 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
- Any usual relative indication against spirometry: ongoing bronchial infections, acute asthma, decompensation of chronic respiratory failure, respiratory pain
- Any usual formal indication against imaging examination PET/CT (important claustrophobia)
- Patient unable to follow study procedures
- Pregnant women or nursing mothers can not participate in the study
- Men and women of childbearing age must use effective contraception at study entry and throughout the study
- Any other medical conditions making the inclusion of the patient in the study inappropriate in the opinion of the investigator
- Patient under legal guardianship
学习计划
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 |
|---|---|
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实验性的:SPI Medical device
SPI medical device used during PET/CT 4D imaging in a synchronized mode centered on the thorax. |
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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):
|
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
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2 years
|
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Measure of BTVrpm (= biologic tumoral volume)
大体时间:2 years
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2 years
|
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Accuracy of detection of maximum inspiratory amplitudes with RPM medical device: evaluated by measuring dtRpm
大体时间:2 years
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dtRpm = standard deviation of the time lag between synchronization signals and maximum inspiratory amplitude for each cycle |
2 years
|
合作者和调查者
调查人员
- 首席研究员:Frederic COURBON, PhD、Institut Claudius Regaud
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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