Clinical trial NCT04341701: Phenotype Identification Based on Multimodal MRI Analysis of Patients With Bronchial Obstructive Diseases
Official title: Phenotype Identification Based on Multimodal MRI Analysis of Patients With Bronchial Obstructive Diseases
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Asthma Copd
Keywords: MRI
multimodal
phenotypes
lung
heart
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2020-04-10
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: diagnostic imaging pilot study, exploratory, prospective, multi-center
Primary purpose: DIAGNOSTIC

Brief 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.

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

.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* 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

Primary outcomes:
measure: Determine the number of the clusters
timeFrame: Day 30
measure: Determine the Quality of the clusters
timeFrame: Day 30
Secondary outcomes:
measure: Assessment of age
timeFrame: Day 1
measure: Assessment of sexe
timeFrame: Day 1
measure: Assessment of tobacco consumption
timeFrame: Day 1
measure: Assessment of disease duration
timeFrame: Day 1
measure: Evaluation score of SF-36 questionnaire
timeFrame: Day 1
measure: Evaluation with St Georges Quality of Life Questionnaire
timeFrame: Day 30
measure: Evaluation of comorbidities
timeFrame: Day 1
measure: Determine of Forced Expiratory Volume in one sec (FEV-1) during spirometry before and after bronchodilator
timeFrame: day 1
measure: Determine of Forced Vital Capacity (FVC) during spirometry before and after bronchodilator
timeFrame: day 1
measure: Determine of slow Vital Capacity (VC) during spirometry before and after bronchodilator
timeFrame: day 1
measure: Determine of Total Lung Capacity (TLC) during spirometry before and after bronchodilator
timeFrame: day 1
measure: Determine of Functional Residual Capacity (FRC) during spirometry before and after bronchodilator
timeFrame: day 1
measure: Determine of Residual Volume (RV) during spirometry before and after bronchodilator
timeFrame: day 1
measure: Determine of Carbon monoxide transfer capacity (TLCO)
timeFrame: day 1
measure: Determine the value of blood heamoglobin
timeFrame: day 1
measure: Determine the value of blood eosinophils
timeFrame: day 1
measure: Determine the value of blood C-reactive protein
timeFrame: day 1
measure: Determine the value of blood B-type natriuretic peptide
timeFrame: day 1
measure: Determine the value of blood total IgE at
timeFrame: day 1
measure: Determine the value of blood total IgE
timeFrame: day 1
Other outcomes:
Locations:
city: Bayonne
country: France
facility: Centre hospitalier de la Côte Basque
city: Bordeaux
country: France
facility: Clinique Saint Augustin
city: Cambo-les-Bains
country: France
facility: Centre Médical Toki Eder
city: Limoges
country: France
facility: Hôpital Le Cluzeau - CHU de Limoges
city: Lormont
country: France
facility: Centre de Pneumologie Bordeaux Rive droite
city: Pessac
country: France
facility: Hôpital Haut-Lévêque - CHU de Bordeaux
Study officials:
affiliation: University Hospital, Bordeaux
name: Patrick BERGER, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: