Trial record 1 of 336 for:    Emphysema
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Assessment of Emphysema Using 1.5T MRI With UTE Pulse Sequences (EMPHYREM)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University Hospital, Bordeaux
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT02100800
First received: March 18, 2014
Last updated: July 4, 2014
Last verified: July 2014
  Purpose

Emphysema is a major pathological feature of Chronic Obstructive Pulmonary Disease (COPD). Non-invasive assessment of emphysema is a crucial issue for the phenotype and follow-up of COPD patients. Currently, CT is the method of reference to evaluate and quantify emphysema but it remains a radiation-based technique. Magnetic Resonance Imagery (MRI) with ultrashort echo time (UTE) pulse sequences is a promising non-ionizing alternative for lung imaging. Our objective is to evaluate emphysema in COPD patients using CT and MR-UTE, and to test the agreement between both techniques.


Condition Intervention
Emphysema
Other: MR and CT measurements of emphysema quantification

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Assessment of Emphysema in COPD Patients Using 1.5T MR Imaging With Ultrashort Echo Time (UTE) Pulse Sequences

Resource links provided by NLM:


Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • Agreement between MRI and CT for evaluating the regional distribution of emphysema [ Time Frame: During MRI and CT, Day one ] [ Designated as safety issue: No ]
    MRI and CT evaluation of regional distribution of emphysema will be assessed by 2 blind radiologists. Agreement between both evaluation will be assessed during statistical analyses after study completion


Secondary Outcome Measures:
  • Agreement between MRI and CT for evaluating the presence of emphysema [ Time Frame: During MRI and CT, Day one ] [ Designated as safety issue: No ]
    MRI and CT evaluation of presence of emphysema will be assessed by 2 blind radiologists. Agreement between both evaluations will be assessed during statistical analyses after study completion

  • Correlation between emphysema scoring extracted from CT and MR images [ Time Frame: During MRI and CT, Day one ] [ Designated as safety issue: No ]
    Emphysema scoring will be assessed by 2 blind radiologists. Correlation between both evaluations will be assessed during statistical analyses after study completion

  • MR emphysema reproductibility scoring over the time [ Time Frame: During MRI, Day one ] [ Designated as safety issue: No ]
    During MRI emphysema scoring will be assessed a second time after 10 minutes wait

  • Comparison of MR emphysema scoring and lung signal values between COPD and controls [ Time Frame: During MRI, Day one ] [ Designated as safety issue: No ]
    MR emphysema scoring and lung signal values collected during MRI will be assessed during statistical analyses after study completion and compared between COPD and controls

  • Comparison of MR emphysema scoring between different GOLD stages [ Time Frame: During MRI, Day one ] [ Designated as safety issue: No ]
    MR emphysema scoring collected during MRI will be assessed during statistical analyses after study completion and compared between different GOLD stages

  • Correlation between MR emphysema scoring and PFT obstructive indexes (FEV1, FEV1/FVC, DEMM25-75) [ Time Frame: During MRI, Day one ] [ Designated as safety issue: No ]
    MR emphysema scoring and PFT obstructive indexes collected during MRI will be assessed during statistical analyses after study completion.

  • Comparison of signal-to-noise and contrast-to-noise ratios of lung parenchyma measured using UTE MRI and classical pulse sequences, as well as image quality assessed using a 4-point scale. [ Time Frame: During MRI, Day one ] [ Designated as safety issue: No ]
    Signal-to-noise and contrast-to-noise ratios of lung parenchyma collected during MRI will be assessed during statistical analyses after study completion and compared between measures using UTE MRI and classical pulse sequences.


Estimated Enrollment: 40
Study Start Date: May 2014
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: COPD Group
30 patients with diagnosis of COPD
Other: MR and CT measurements of emphysema quantification
Sham Comparator: Control Group
10 volunteers with extrapulmonary neoplasia
Other: MR and CT measurements of emphysema quantification

Detailed Description:

COPD is a major public health problem and is pathologically characterized by lung emphysema and bronchial remodeling. Emphysema is defined as an irreversible destruction of alveolar walls and subsequent enlargement of air spaces. New targeted therapies against emphysema are currently developed, thereby stressing the need for non-invasive tools aimed at quantifying emphysema. Multi-slice computed tomography (CT) is the method of reference to quantify emphysema but involves ionizing radiation, thus limiting the possibility of long-term follow-up. MRI is a non-ionizing 3D imaging technique; however, lung MRI is technically challenging with the result that it is currently not used in routine practice. Indeed, both low proton density and susceptibility effects lead to a very low signal intensity derived from lung parenchyma. Recently, pulse sequences with ultrashort echo time (UTE) have been implemented by the use of half radio-frequency excitations and radial projection reconstruction. These UTE sequences make it theoretically possible to retrieve more signal from the lung parenchyma. We aim at using 3D T1-weighted UTE pulse sequences on a 1.5T magnet (Avanto dot, Siemens) in COPD patients in order to distinguish normal lung from emphysematous areas. Thirty COPD patients and 10 volunteers are expected to take part in the study. All will benefit from Pulmonary Functional Testing (PFT), CT and MRI. Our strategy will consist in quantifying pulmonary emphysema using MRI and CT in those subjects, testing for correlations between MR and CT measurements and assessing the reproducibility of emphysema quantification using MRI. Our objective is to demonstrate that MR-UTE pulse sequence at 1.5T is accurate and reproducible in evaluating and quantifying pulmonary emphysema.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female aged more than 40 years.
  • COPD group: patients with diagnosis of COPD at distance (minimum 4 weeks) from any acute exacerbation; staging 1-4 according to 2010 GOLD guidelines. PFTs and chest CT-scan should be available within a maximum of 30 days before inclusion.
  • Control group: subjects without any chronic symptoms such as cough or expectoration (St-Georges symptoms scoring < 5%), with normal chest CT-scans performed in the pretherapeutic work-up of extrapulmonary cancers within a maximum of 30 days before inclusion. These subjects will be age- and sex-matched with COPD patients.
  • With a written informed consent and health insurance.

Exclusion Criteria:

  • Subjects without any social security or health insurance.
  • History of asthma, lung fibrosis, pulmonary hypertension or cystic fibrosis.
  • Pregnancy.
  • Any respiratory treatment for control subjects.
  • MRI contraindications: Magnetically activated implanted devices (cardiac pacemakers, insulin pumps, neurostimulators, cochlear implants), metal inside the eye or the brain (aneurysm clip, ocular foreign body), cardiac valvular prosthesis (Starr-Edwards pre-6000), subject with claustrophobia.
  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: NCT02100800

Contacts
Contact: Gaël DOURNES, MD gael.dournes@chu-bordeaux.fr

Locations
France
University Hospital Bordeaux Recruiting
Pessac, France, 33604
Contact: Gaël DOURNES, MD       gael.dournes@chu-bordeaux.fr   
Contact: Virginie NIEL       virginie.niel@chu-bordeaux.fr   
Principal Investigator: Gaël DOURNES, MD         
Sub-Investigator: Patrick BERGER, MD         
Sub-Investigator: Pierre-Olivier GIRODET, MD         
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
Principal Investigator: Gaël DOURNES, MD University Hospital Bordeaux (France)
  More Information

No publications provided

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT02100800     History of Changes
Other Study ID Numbers: CHUBX 2012/09, 2013-A00353-42
Study First Received: March 18, 2014
Last Updated: July 4, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by University Hospital, Bordeaux:
COPD
Emphysema
MRI
UTE
Quantification
CT

Additional relevant MeSH terms:
Emphysema
Pulmonary Emphysema
Pathologic Processes
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 31, 2014