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

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Non Small Cell Lung Cancer, Lung Nodule

Intervention / Treatment
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* Device: PET/CT 4D imaging in a synchronized mode centered on the thorax.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 WHO ≤ 1 Well-informed written consent signed by the patient and collected before any specific procedure in the study 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SPI Medical device<br>SPI medical device used during PET/CT 4D imaging in a synchronized mode centered on the thorax. | Device: PET/CT 4D imaging in a synchronized mode centered on the thorax.<br> <br> |
| Active Comparator: reference medical device : RPM<br>Reference medical device (RPM) used simultaneously during PET/CT 4D imaging in a synchronized mode centered on the thorax. | Device: PET/CT 4D imaging in a synchronized mode centered on the thorax.<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of the PET/CT synchronized exam with SPI device (success or failure ) | feasibility is evaluated in a composite end point (success will be obtained in case of concomitant success of the 4 sub-criteria assessment): Tolerance / acceptability of the patient to breathe into SPI throughout the examination) Detection of breath cycle of the patient by measuring dCycleSpi (dCycleSpi = Number of synchronization signals emitted by SPI / total number of breath cycle * 100). 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). Production of images with a correct segmentation of BTV during PET/CT synchronized exam with SPI device | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of dCycleRpm (dCycleRpmi = Number of synchronization signals emitted by RPM / total number of breath cycle * 100) |  | 2 years | 
| Accuracy of detection of maximum inspiratory amplitudes with RPM medical device: evaluated by measuring dtRpm | 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) |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung Cancer, PET/CT, FDG, Respiratory synchronization