Asthma CopdPIMABODNCT04341701
Phenotype Identification Based on Multimodal MRI Analysis of Patients With Bronchial Obstructive Diseases
A study testing MRI in people with Asthma Copd, run by University Hospital, Bordeaux at 6 sites in France.
Trial summary
The hypothesis is that pulmonary and cardiac proton MRI allows phenotyping of patients with bronchial obstruction by cluster analysis based on quantitative multimodal imaging of bronchi, pulmonary vessels, pulmonary parenchyma, right and left ventricular function, myocardial fibrosis and pulmonary arterial pressure. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Asthma Copd
- What is being tested?
- MRI
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 6 sitesFrance
- Study dates
- 5 Aug 2021to 30 Mar 2024
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Man or woman aged between 40 and 70 years.
- Having benefited under the current care of spirometry showing FEV / FVC pre-bronchodilation <0.70 at steady state (i.e., without exacerbation from at least 4 weeks).
- Having a diagnosis of asthma according to GINA 2019 without smoking restrictions or COPD according to GOLD 2019 but unrestricted to any level of bronchial reversibility to bronchodilator established by the pulmonologist.
- On stable cardiopulmonary medications for at least 4 weeks
- Having given his written informed consent.
Who cannot join
- Subject deprived of liberty by judicial or administrative decision.
- Major protected by law.
- Subject not affiliated to a social security scheme, whether or not the beneficiary of such a regime.
- Pregnant or breastfeeding women
- Inability to complete the Questionnaire SF-36 and SGQLQ.
- Subject in times of exclusion in relation to another protocol.
Show all 15Show fewer
- History of pulmonary fibrosis, primary pulmonary hypertension and cystic fibrosis.
- History of lung resection (referred to oncological or volume reduction)
- History of cancer except skin cancer (squamous and Basal) under 5 years
- History of chest radiation
- Pacemaker carrier subject or implantable defibrillator, intraocular metallic foreign body, metal clip intracranial, heart valve prosthesis kind Starr-Edwards pre-6000, or biomedical insulin pump type device, Neurostimulator or cochlear implant, Metal patches.
- Subject claustrophobic or unable to stay elongate during 30 minutes.
- Subject with a waist circumference greater than 200 cm.
- Occurrence of an exacerbation between the FE and MRI
- Uninterpretable MRI
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Centre hospitalier de la Côte Basque
Bayonne, 64100
Clinique Saint Augustin
Bordeaux, 33000
Centre Médical Toki Eder
Cambo-les-Bains, 64250
Hôpital Le Cluzeau - CHU de Limoges
Limoges, 87000
Centre de Pneumologie Bordeaux Rive droite
Lormont, 33310
Hôpital Haut-Lévêque - CHU de Bordeaux
Pessac, 33600
About this study
The hypothesis is that pulmonary and cardiac proton MRI allows phenotyping of patients with bronchial obstruction by cluster analysis based on quantitative multimodal imaging of bronchi, pulmonary vessels, pulmonary parenchyma, right and left ventricular function, myocardial fibrosis and pulmonary arterial pressure.
Such imaging will also offer the advantage of being non-irradiating and without contrast products, which will ultimately allow CT to be replaced by MRI in the follow-up of bronchial obstructive patients, thus avoiding the risks associated with repeated exposure to ionizing radiation.
Read the detailed description
Bronchial obstructive diseases such as asthma and chronic obstructive pulmonary disease (COPD) are very common and represent a major public health problem. The distinction between these two diseases is sometimes difficult. In each of these diseases, several clinical phenotypes or biological endotypes have been defined. For example, frequent exacerbating patients and / or hypereosinophilic patients are present in both diseases. In the severe states, cardiovascular comorbidities are the most frequent comorbidities and alter the prognosis.
In these chronic obstructive patients, computed tomography (CT) allows a multimodal analysis of the bronchial wall, the lung parenchyma and pulmonary vessels. CT also allows a score analysis of coronary plaques. However, irradiation is significant and increases with repeated examinations. CT does not allow a comprehensive analysis of cardiac function, or an estimate of pulmonary artery pressure.
Magnetic Resonance Imaging (MRI) is a proton non-ionizing alternative to CT, in particular when using 3D ultra-short echo-time (UTE) sequences. These 3D-UTE sequences decrease the effects of magnetic susceptibility and provide morphological and morphometric information on bronchi and lung comparable to those obtained by CT. Moreover, dedicated sequences add functional information on bronchi. Heart MRI allows more analyses, such as right and left ventricular systolic functions, an indirect estimate of pulmonary arterial pressure and the amount of diffuse myocardial fibrosis.
Our project aims to identify morphological phenotypes through the pulmonary and heart MRI in patients with obstructive lung disease
.
- Conditions
- Asthma Copd
- Being tested
- MRI
- Keywords
- MRI, multimodal, phenotypes, lung, heart
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIProcedure or surgery
The procedure to study lung and heart MRI, performed on a 1.5T magnet (Siemens), without any injection or inhalation of contrast agent
| Study group | Role | What they receive |
|---|---|---|
| COPD | Other | COPD according to GOLD 2019 but unrestricted to any level of bronchial reversibility established by the pulmonologist Receives: Procedure: MRI |
| Asthma | Other | asthma according to GINA 2019 but without any smoking restriction Receives: Procedure: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the number of the clusters
Number of the clusters will be defined using principal component analysis and dendrogram, based on the multimodal lung and heart MRI analysis
Measured: Day 30
Determine the Quality of the clusters
Quality of the clusters will be defined using Dunn index and non-hierarchical analysis based on the multimodal lung and heart MRI analysis
Measured: Day 30
Secondary outcomes (20)
Assessment of age
Measured: Day 1
Assessment of sexe
Measured: Day 1
Assessment of tobacco consumption
Measured: Day 1
Assessment of disease duration
Measured: Day 1
Evaluation score of SF-36 questionnaire
Determine the quality of life. SF36: 36-Item Short Form health survey Minimum = 0 and maximum = 100 Higher score means better outcome
Measured: Day 1
Evaluation with St Georges Quality of Life Questionnaire
Determine the quality of life. Minimum = 0 and maximum = 100 Higher score means worse outcome
Measured: Day 30
Evaluation of comorbidities
The presence of various comorbidities will be checked in a yes/No manner :
- rhinitis
- sinusitis
- nasal polyposis
- gastroesophageal reflux
- obstructive sleep apnea
- depression
- anxiety
- allery
- heart failure (Left or Right)
- hypertension
- myocardial infarction
- stroke
- arteriopathy
- arythmia
- diabetis
- dyslipidaemia
- obesity
- denutrition
- osteoporosis
Measured: Day 1
Determine of Forced Expiratory Volume in one sec (FEV-1) during spirometry before and after bronchodilator
Assessment of FEV-1/FVC during spirometry before and after bronchodilator
Measured: day 1
Determine of Forced Vital Capacity (FVC) during spirometry before and after bronchodilator
Assessment of FEV-1/FVC during spirometry before and after bronchodilator
Measured: day 1
Determine of slow Vital Capacity (VC) during spirometry before and after bronchodilator
Measured: day 1
Determine of Total Lung Capacity (TLC) during spirometry before and after bronchodilator
Measured: day 1
Determine of Functional Residual Capacity (FRC) during spirometry before and after bronchodilator
Measured: day 1
Determine of Residual Volume (RV) during spirometry before and after bronchodilator
Measured: day 1
Determine of Carbon monoxide transfer capacity (TLCO)
Measured: day 1
Determine the value of blood heamoglobin
Measured: day 1
Determine the value of blood eosinophils
Measured: day 1
Determine the value of blood C-reactive protein
Measured: day 1
Determine the value of blood B-type natriuretic peptide
Measured: day 1
Determine the value of blood total IgE at
Measured: day 1
Determine the value of blood total IgE
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2020
- Study start5 Aug 2021
- Primary completion30 Mar 2024 (estimated)
- Study completion30 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma CopdStudies 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
- Model description
- diagnostic imaging pilot study, exploratory, prospective, multi-center
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick BERGER, MD, PhD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04341701
- Sponsor's protocol ID
- CHUBX 2018/37
- Acronym
- PIMABOD
- Status last verified
- Feb 2024
- First submitted
- 2 Apr 2020
- Last updated
- 2 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phenotype Identification Based on Multimodal MRI Analysis of Patients With Bronchial Obstructive Diseases
- ClinicalTrials.gov ID
- NCT04341701
- Acronym / sponsor ID
- PIMABOD / CHUBX 2018/37
- Conditions
- Asthma Copd
- Keywords
- MRI, multimodal, phenotypes, lung, heart
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 5 Aug 2021 (actual)
- Primary completion
- 30 Mar 2024 (estimated)
- Study completion
- 30 Mar 2024 (estimated)
- First posted
- 10 Apr 2020 (actual)
- 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.
The hypothesis is that pulmonary and cardiac proton MRI allows phenotyping of patients with bronchial obstruction by cluster analysis based on quantitative multimodal imaging of bronchi, pulmonary vessels, pulmonary parenchyma, right and left ventricular function, myocardial fibrosis and pulmonary arterial pressure.
Such imaging will also offer the advantage of being non-irradiating and without contrast products, which will ultimately allow CT to be replaced by MRI in the follow-up of bronchial obstructive patients, thus avoiding the risks associated with repeated exposure to ionizing radiation.
Detailed description
Bronchial obstructive diseases such as asthma and chronic obstructive pulmonary disease (COPD) are very common and represent a major public health problem. The distinction between these two diseases is sometimes difficult. In each of these diseases, several clinical phenotypes or biological endotypes have been defined. For example, frequent exacerbating patients and / or hypereosinophilic patients are present in both diseases. In the severe states, cardiovascular comorbidities are the most frequent comorbidities and alter the prognosis.
In these chronic obstructive patients, computed tomography (CT) allows a multimodal analysis of the bronchial wall, the lung parenchyma and pulmonary vessels. CT also allows a score analysis of coronary plaques. However, irradiation is significant and increases with repeated examinations. CT does not allow a comprehensive analysis of cardiac function, or an estimate of pulmonary artery pressure.
Magnetic Resonance Imaging (MRI) is a proton non-ionizing alternative to CT, in particular when using 3D ultra-short echo-time (UTE) sequences. These 3D-UTE sequences decrease the effects of magnetic susceptibility and provide morphological and morphometric information on bronchi and lung comparable to those obtained by CT. Moreover, dedicated sequences add functional information on bronchi. Heart MRI allows more analyses, such as right and left ventricular systolic functions, an indirect estimate of pulmonary arterial pressure and the amount of diffuse myocardial fibrosis.
Our project aims to identify morphological phenotypes through the pulmonary and heart MRI in patients with obstructive lung disease
.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- diagnostic imaging pilot study, exploratory, prospective, multi-center
| Arm | Type | Receives |
|---|---|---|
| COPD | Other | Procedure: MRICOPD according to GOLD 2019 but unrestricted to any level of bronchial reversibility established by the pulmonologist |
| Asthma | Other | Procedure: MRIasthma according to GINA 2019 but without any smoking restriction |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Man or woman aged between 40 and 70 years.
- Having benefited under the current care of spirometry showing FEV / FVC pre-bronchodilation <0.70 at steady state (i.e., without exacerbation from at least 4 weeks).
- Having a diagnosis of asthma according to GINA 2019 without smoking restrictions or COPD according to GOLD 2019 but unrestricted to any level of bronchial reversibility to bronchodilator established by the pulmonologist.
- On stable cardiopulmonary medications for at least 4 weeks
- Having given his written informed consent.
Key exclusion criteria (15 listed)
- Subject deprived of liberty by judicial or administrative decision.
- Major protected by law.
- Subject not affiliated to a social security scheme, whether or not the beneficiary of such a regime.
- Pregnant or breastfeeding women
- Inability to complete the Questionnaire SF-36 and SGQLQ.
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 |
|---|---|---|
| MRIThe procedure to study lung and heart MRI, performed on a 1.5T magnet (Siemens), without any injection or inhalation of contrast agent | Procedure or surgery | Asthma, COPD |
Primary outcome
Determine the number of the clusters
Time frame: Day 30
Number of the clusters will be defined using principal component analysis and dendrogram, based on the multimodal lung and heart MRI analysis
Determine the Quality of the clusters
Time frame: Day 30
Quality of the clusters will be defined using Dunn index and non-hierarchical analysis based on the multimodal lung and heart MRI analysis
20 secondary outcomes
Assessment of age
Time frame: Day 1
Assessment of sexe
Time frame: Day 1
Assessment of tobacco consumption
Time frame: Day 1
Assessment of disease duration
Time frame: Day 1
Evaluation score of SF-36 questionnaire
Time frame: Day 1
Evaluation with St Georges Quality of Life Questionnaire
Time frame: Day 30
Evaluation of comorbidities
Time frame: Day 1
Determine of Forced Expiratory Volume in one sec (FEV-1) during spirometry before and after bronchodilator
Time frame: day 1
Determine of Forced Vital Capacity (FVC) during spirometry before and after bronchodilator
Time frame: day 1
Determine of slow Vital Capacity (VC) during spirometry before and after bronchodilator
Time frame: day 1
Determine of Total Lung Capacity (TLC) during spirometry before and after bronchodilator
Time frame: day 1
Determine of Functional Residual Capacity (FRC) during spirometry before and after bronchodilator
Time frame: day 1
Determine of Residual Volume (RV) during spirometry before and after bronchodilator
Time frame: day 1
Determine of Carbon monoxide transfer capacity (TLCO)
Time frame: day 1
Determine the value of blood heamoglobin
Time frame: day 1
Determine the value of blood eosinophils
Time frame: day 1
Determine the value of blood C-reactive protein
Time frame: day 1
Determine the value of blood B-type natriuretic peptide
Time frame: day 1
Determine the value of blood total IgE at
Time frame: day 1
Determine the value of blood total IgE
Time frame: day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2024.
- Individual participant dataSharing planned: No
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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.
Patrick BERGER, MD, PhD principal investigator
University Hospital, Bordeaux
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI in people with Asthma Copd, run by University Hospital, Bordeaux at 6 sites 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 5 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 2 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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. 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?
Results are not available in the source record.
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?
Determine the number of the clusters (time frame: Day 30). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Feb 2024.