Clinical trial NCT01720186: Evaluation of a Pneumotachograph (SPI) for the Production of PET and CT Acquisitions Synchronized With Breath for the Assessment of Extension of Lung Cancer
Official title: 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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Non Small Cell Lung Cancer
Lung Nodule
Keywords: Lung Cancer
PET/CT
FDG
Respiratory synchronization
Lead sponsor: Institut Claudius Regaud
Sponsor class: OTHER
First posted: 2012-11-02
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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).


Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of the PET/CT synchronized exam with SPI device ("success" or "failure" )
timeFrame: 2 years
Secondary outcomes:
measure: Measure of dCycleRpm (dCycleRpmi = Number of synchronization signals emitted by RPM / total number of breath cycle * 100)
timeFrame: 2 years
measure: Accuracy of detection of maximum inspiratory amplitudes with RPM medical device: evaluated by measuring dtRpm
timeFrame: 2 years
measure: Measure of BTVrpm (= biologic tumoral volume)
timeFrame: 2 years
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Institut Claudius REGAUD
Study officials:
affiliation: Institut Claudius Regaud
name: Frederic COURBON, PhD
role: PRINCIPAL_INVESTIGATOR
References: