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

Non Small Cell Lung Cancer Clinical Trial

— SPI COHERENCE  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01720186
• Other study ID #: 12POUM01
• Status: Terminated
• Phase: N/A
• First received: October 12, 2012
• Last updated: October 8, 2014
• Start date: May 2013
• Est. completion date: September 2014

Study information

• Verified date: September 2014
• Source: Institut Claudius Regaud
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 46
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Lung Nodule
• Non Small Cell Lung Cancer

Intervention

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

Locations

Country	Name	City	State
France	Institut Claudius REGAUD	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Institut Claudius Regaud

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Measure of dCycleRpm (dCycleRpmi = Number of synchronization signals emitted by RPM / total number of breath cycle * 100)		2 years	No
Secondary	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	No
Secondary	Measure of BTVrpm (= biologic tumoral volume)		2 years	No