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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPI Medical device | Experimental | SPI medical device used during PET/CT 4D imaging in a synchronized mode centered on the thorax. |
|
| reference medical device : RPM | Active Comparator | Reference medical device (RPM) used simultaneously during PET/CT 4D imaging in a synchronized mode centered on the thorax. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PET/CT 4D imaging in a synchronized mode centered on the thorax. | Device |
|
| 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):
| 2 years |
| 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 |
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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 :
Patient who meets the following criteria to be eligible for an PET/CT imaging:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Frederic COURBON, PhD | Institut Claudius Regaud | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Claudius REGAUD | Toulouse | 31052 | France |
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| 2 years |
| Measure of BTVrpm (= biologic tumoral volume) | 2 years |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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