Evaluation of a Pneumotachograph (SPI) for the Production of PET and CT Acquisitions Synchronized With Breath for the Assessment of Extension of Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Feasibility of the PET/CT synchronized exam with SPI device ("success" or "failure" )
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •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)
- •Age ≥ 18 years
- •Well-informed written consent signed by the patient and collected before any specific procedure in the study
- •Patient member in a national insurance scheme
排除标准
- •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
结局指标
主要结局
Feasibility of the PET/CT synchronized exam with SPI device ("success" or "failure" )
时间窗: 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"
次要结局
- Measure of dCycleRpm (dCycleRpmi = Number of synchronization signals emitted by RPM / total number of breath cycle * 100)(2 years)
- Measure of BTVrpm (= biologic tumoral volume)(2 years)
- Accuracy of detection of maximum inspiratory amplitudes with RPM medical device: evaluated by measuring dtRpm(2 years)