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 study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Institut Claudius Regaud
Sponsor:
Information provided by (Responsible Party):
Institut Claudius Regaud
ClinicalTrials.gov Identifier:
NCT01720186
First received: October 12, 2012
Last updated: May 29, 2013
Last verified: May 2013
  Purpose

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).


Condition Intervention
Non Small Cell Lung Cancer
Lung Nodule
Device: PET/CT 4D imaging in a synchronized mode centered on the thorax.

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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

Resource links provided by NLM:


Further study details as provided by Institut Claudius Regaud:

Primary Outcome Measures:
  • Feasibility of the PET/CT synchronized exam with SPI device ("success" or "failure" ) [ Time Frame: 2 years ] [ Designated as safety issue: No ]

    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"


Secondary Outcome Measures:
  • Measure of dCycleRpm (dCycleRpmi = Number of synchronization signals emitted by RPM / total number of breath cycle * 100) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Accuracy of detection of maximum inspiratory amplitudes with RPM medical device: evaluated by measuring dtRpm [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    dtRpm = standard deviation of the time lag between synchronization signals and maximum inspiratory amplitude for each cycle

  • Measure of BTVrpm (= biologic tumoral volume) [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 55
Study Start Date: May 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01720186

Contacts
Contact: Frederic MD COURBON, PhD +33 5.67.69.63.20 courbon.frederic@claudiusregaud.fr

Locations
France
Institut Claudius REGAUD Recruiting
Toulouse, France, 31052
Contact: Frederic COURBON, PhD    +33 5.67.69.63.20    courbon.frederic@claudiusregaud.fr   
Principal Investigator: Frederic COURBON, PhD         
Sub-Investigator: Slimane ZERDOUD, PhD         
Sub-Investigator: Lawrence DIERICKX, PhD         
Sponsors and Collaborators
Institut Claudius Regaud
Investigators
Principal Investigator: Frederic COURBON, PhD Institut Claudius Regaud
  More Information

No publications provided

Responsible Party: Institut Claudius Regaud
ClinicalTrials.gov Identifier: NCT01720186     History of Changes
Other Study ID Numbers: 12POUM01
Study First Received: October 12, 2012
Last Updated: May 29, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Institut Claudius Regaud:
Lung Cancer
PET/CT
FDG
Respiratory synchronization

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 24, 2014