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

NCT01720186 | Terminated

• 1 other identifier: 12POUM01
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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).

Conditions

Non Small Cell Lung Cancer; Lung Nodule

Keywords

Lung Cancer; PET/CT; FDG; Respiratory synchronization

Outcome Measures

Primary Outcomes (1)

• 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): 1. Tolerance / acceptability of the patient to breathe into SPI throughout the examination) 2. Detection of breath cycle of the patient by measuring dCycleSpi (dCycleSpi = Number of synchronization signals emitted by SPI / total number of breath cycle \* 100). 3. 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). 4. Production of images with a correct segmentation of BTV during PET/CT synchronized exam with SPI device"

  2 years

Secondary Outcomes (3)

• 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

  2 years

• Measure of BTVrpm (= biologic tumoral volume)

  2 years

Study Arms (2)

SPI Medical device

EXPERIMENTAL

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.

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.

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

Interventions

PET/CT 4D imaging in a synchronized mode centered on the thorax. DEVICE

SPI Medical device; reference medical device : RPM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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)
• 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

You may not qualify if:

• Patient with a bronchial carcinoid or bronchoalveolar cancer
• Patient with acute bronchopneumopathy
• Not stabilized diabetic patient
• 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
• Any usual relative indication against spirometry: ongoing bronchial infections, acute asthma, decompensation of chronic respiratory failure, respiratory pain
• Any usual formal indication against imaging examination PET/CT (important claustrophobia)
• Patient unable to follow study procedures
• Pregnant women or nursing mothers can not participate in the study
• Men and women of childbearing age must use effective contraception at study entry and throughout the study
• Patient under legal guardianship

Sponsors & Collaborators

• Institut Claudius Regaud: lead

Study Sites (1)

Institut Claudius REGAUD

Toulouse, 31052, France

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Frederic COURBON, PhD

  Institut Claudius Regaud

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2012
• First Posted: November 2, 2012
• Study Start: May 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: October 9, 2014

Record last verified: 2014-09

Locations

FR (1)