EmphysemaEMPHYREMNCT02100800
Assessment of Emphysema Using 1.5T MRI With UTE Pulse Sequences
A study testing MR and CT measurements of emphysema quantification in people with Emphysema, run by University Hospital, Bordeaux at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Emphysema
- What is being tested?
- MR and CT measurements of emphysema quantification
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteFrance
- Study dates
- 23 May 2014to 13 Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Emphysema in COPD Patients Using 1.5T MR Imaging With Ultrashort Echo Time (UTE) Pulse Sequences
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.
Read the 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.
- Conditions
- Emphysema
- Being tested
- MR and CT measurements of emphysema quantification
- Keywords
- COPD, Emphysema, MRI, UTE, Quantification, CT
- Medical subject headings
- Emphysema, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR and CT measurements of emphysema quantificationOther
| Study group | Role | What they receive |
|---|---|---|
| COPD Group | Experimental | 30 patients with diagnosis of COPD Receives: Other: MR and CT measurements of emphysema quantification |
| Control Group | Sham comparator | 10 volunteers with extrapulmonary neoplasia Receives: Other: MR and CT measurements of emphysema quantification |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: During MRI and CT, Day one
Secondary outcomes (7)
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
Measured: During MRI and CT, Day one
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
Measured: During MRI and CT, Day one
MR emphysema reproductibility scoring over the time
During MRI emphysema scoring will be assessed a second time after 10 minutes wait
Measured: During MRI, Day one
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
Measured: During MRI, Day one
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
Measured: During MRI, Day one
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.
Measured: During MRI, Day one
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.
Measured: During MRI, Day one
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2014 (estimated)
- Study start23 May 2014
- Primary completion13 Jul 2016
- Study completion13 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EmphysemaStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gaël DOURNES, MD, Principal investigator, University Hospital Bordeaux (France)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02100800
- Sponsor's protocol ID
- CHUBX 2012/09
- Other IDs
- 2013-A00353-42
- Acronym
- EMPHYREM
- Status last verified
- Feb 2022
- First submitted
- 18 Mar 2014
- Last updated
- 9 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31161972
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Emphysema in COPD Patients Using 1.5T MR Imaging With Ultrashort Echo Time (UTE) Pulse Sequences
- ClinicalTrials.gov ID
- NCT02100800
- Acronym / sponsor ID
- EMPHYREM / CHUBX 2012/09
- Conditions
- Emphysema
- Keywords
- COPD, Emphysema, MRI, UTE, Quantification, CT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 23 May 2014 (actual)
- Primary completion
- 13 Jul 2016 (actual)
- Study completion
- 13 Jul 2016 (actual)
- First posted
- 1 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COPD Group | Experimental | Other: MR and CT measurements of emphysema quantification30 patients with diagnosis of COPD |
| Control Group | Sham comparator | Other: MR and CT measurements of emphysema quantification10 volunteers with extrapulmonary neoplasia |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MR and CT measurements of emphysema quantification | Other | COPD Group, Control Group |
Primary outcome
Agreement between MRI and CT for evaluating the regional distribution of emphysema
Time frame: During MRI and CT, Day one
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
7 secondary outcomes
Agreement between MRI and CT for evaluating the presence of emphysema
Time frame: During MRI and CT, Day one
Correlation between emphysema scoring extracted from CT and MR images
Time frame: During MRI and CT, Day one
MR emphysema reproductibility scoring over the time
Time frame: During MRI, Day one
Comparison of MR emphysema scoring and lung signal values between COPD and controls
Time frame: During MRI, Day one
Comparison of MR emphysema scoring between different GOLD stages
Time frame: During MRI, Day one
Correlation between MR emphysema scoring and PFT obstructive indexes (FEV1, FEV1/FVC, DEMM25-75)
Time frame: During MRI, Day one
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2022.
- Derived from this study: PubMed 31161972Benlala 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gaël DOURNES, MD principal investigator
University Hospital Bordeaux (France)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MR and CT measurements of emphysema quantification in people with Emphysema, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement between MRI and CT for evaluating the regional distribution of emphysema (time frame: During MRI and CT, Day one). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02100800, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2022.