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

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).

Study Overview

• Status: Terminated
• Conditions: Non Small Cell Lung Cancer; Lung Nodule
• Intervention / Treatment: Device: PET/CT 4D imaging in a synchronized mode centered on the thorax.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Toulouse, France, 31052
    • Institut Claudius Regaud

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SPI Medical device; 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.
Active Comparator: reference medical device : RPM; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Institut Claudius Regaud
• Investigators: Principal Investigator: Frederic COURBON, PhD, Institut Claudius Regaud

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: October 12, 2012
• First Submitted That Met QC Criteria: October 31, 2012
• First Posted (Estimate): November 2, 2012

Study Record Updates

• Last Update Posted (Estimate): October 9, 2014
• Last Update Submitted That Met QC Criteria: October 8, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: Lung Cancer; PET/CT; FDG; Respiratory synchronization
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 12POUM01