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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

18 Years
Open (Enrolling)
Non Small Cell Lung Cancer, Lung Nodule

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Trial Information

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

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

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Feasibility of the PET/CT synchronized exam with SPI device ("success" or "failure" )

Outcome Description:

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"

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Frederic COURBON, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Institut Claudius Regaud


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:




Start Date:

May 2013

Completion Date:

December 2014

Related Keywords:

  • Non Small Cell Lung Cancer
  • Lung Nodule
  • Lung Cancer
  • PET/CT
  • FDG
  • Respiratory synchronization
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms