Phenotype Identification Based on Multimodal MRI Analysis of Patients With Bronchial Obstructive Diseases

NCT ID: NCT04341701

Last Updated: 2024-02-02

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-05
• Study Completion Date: 2024-03-30

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

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Conditions

Asthma Copd

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

COPD

COPD according to GOLD 2019 but unrestricted to any level of bronchial reversibility established by the pulmonologist

Group Type: OTHER

MRI

Intervention Type: PROCEDURE

The procedure to study lung and heart MRI, performed on a 1.5T magnet (Siemens), without any injection or inhalation of contrast agent

Asthma

asthma according to GINA 2019 but without any smoking restriction

Group Type: OTHER

MRI

Intervention Type: PROCEDURE

The procedure to study lung and heart MRI, performed on a 1.5T magnet (Siemens), without any injection or inhalation of contrast agent

Interventions

MRI

The procedure to study lung and heart MRI, performed on a 1.5T magnet (Siemens), without any injection or inhalation of contrast agent

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patrick BERGER, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Locations

Centre hospitalier de la Côte Basque

Bayonne, , France

Clinique Saint Augustin

Bordeaux, , France

Centre Médical Toki Eder

Cambo-les-Bains, , France

Hôpital Le Cluzeau - CHU de Limoges

Limoges, , France

Centre de Pneumologie Bordeaux Rive droite

Lormont, , France

Hôpital Haut-Lévêque - CHU de Bordeaux

Pessac, , France

Countries

France

Other Identifiers

CHUBX 2018/37

Identifier Type: -

Identifier Source: org_study_id