Assessment of Emphysema Using 1.5T MRI With UTE Pulse Sequences (EMPHYREM)
Primary Purpose
Emphysema
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MR and CT measurements of emphysema quantification
Sponsored by
About this trial
This is an interventional diagnostic trial for Emphysema focused on measuring COPD, Emphysema, MRI, UTE, Quantification, CT
Eligibility 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.
Sites / Locations
- University Hospital Bordeaux
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
COPD Group
Control Group
Arm Description
30 patients with diagnosis of COPD
10 volunteers with extrapulmonary neoplasia
Outcomes
Primary Outcome Measures
Agreement between MRI and CT for evaluating the regional distribution of emphysema
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
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
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
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
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
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)
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.
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.
Full Information
NCT ID
NCT02100800
First Posted
March 18, 2014
Last Updated
February 8, 2022
Sponsor
University Hospital, Bordeaux
1. Study Identification
Unique Protocol Identification Number
NCT02100800
Brief Title
Assessment of Emphysema Using 1.5T MRI With UTE Pulse Sequences
Acronym
EMPHYREM
Official Title
Assessment of Emphysema in COPD Patients Using 1.5T MR Imaging With Ultrashort Echo Time (UTE) Pulse Sequences
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
May 23, 2014 (Actual)
Primary Completion Date
July 13, 2016 (Actual)
Study Completion Date
July 13, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emphysema
Keywords
COPD, Emphysema, MRI, UTE, Quantification, CT
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
COPD Group
Arm Type
Experimental
Arm Description
30 patients with diagnosis of COPD
Arm Title
Control Group
Arm Type
Sham Comparator
Arm Description
10 volunteers with extrapulmonary neoplasia
Intervention Type
Other
Intervention Name(s)
MR and CT measurements of emphysema quantification
Primary Outcome Measure Information:
Title
Agreement between MRI and CT for evaluating the regional distribution of emphysema
Description
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
Time Frame
During MRI and CT, Day one
Secondary Outcome Measure Information:
Title
Agreement between MRI and CT for evaluating the presence of emphysema
Description
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
Time Frame
During MRI and CT, Day one
Title
Correlation between emphysema scoring extracted from CT and MR images
Description
Emphysema scoring will be assessed by 2 blind radiologists. Correlation between both evaluations will be assessed during statistical analyses after study completion
Time Frame
During MRI and CT, Day one
Title
MR emphysema reproductibility scoring over the time
Description
During MRI emphysema scoring will be assessed a second time after 10 minutes wait
Time Frame
During MRI, Day one
Title
Comparison of MR emphysema scoring and lung signal values between COPD and controls
Description
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
Time Frame
During MRI, Day one
Title
Comparison of MR emphysema scoring between different GOLD stages
Description
MR emphysema scoring collected during MRI will be assessed during statistical analyses after study completion and compared between different GOLD stages
Time Frame
During MRI, Day one
Title
Correlation between MR emphysema scoring and PFT obstructive indexes (FEV1, FEV1/FVC, DEMM25-75)
Description
MR emphysema scoring and PFT obstructive indexes collected during MRI will be assessed during statistical analyses after study completion.
Time Frame
During MRI, Day one
Title
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.
Description
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.
Time Frame
During MRI, Day one
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gaël DOURNES, MD
Organizational Affiliation
University Hospital Bordeaux (France)
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Bordeaux
City
Pessac
ZIP/Postal Code
33604
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
31161972
Citation
Benlala I, Berger P, Girodet PO, Dromer C, Macey J, Laurent F, Dournes G. Automated Volumetric Quantification of Emphysema Severity by Using Ultrashort Echo Time MRI: Validation in Participants with Chronic Obstructive Pulmonary Disease. Radiology. 2019 Jul;292(1):216-225. doi: 10.1148/radiol.2019190052. Epub 2019 Jun 4.
Results Reference
derived
Learn more about this trial
Assessment of Emphysema Using 1.5T MRI With UTE Pulse Sequences
We'll reach out to this number within 24 hrs