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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Asthma Copd
• Intervention / Treatment: Procedure: MRI

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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• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Virginie NIEL; Phone Number: +335 57 62 31 94; Email: virginie.niel@chu-bordeaux.fr

Study Locations

• France
  • Bayonne, France, 64100
    • Centre Hospitalier de la Cote Basque
  • Bordeaux, France, 33000
    • Clinique Saint Augustin
  • Cambo-les-Bains, France, 64250
    • Centre Médical Toki Eder
  • Limoges, France, 87000
    • Hôpital Le Cluzeau - CHU de Limoges
  • Lormont, France, 33310
    • Centre de Pneumologie Bordeaux Rive droite
  • Pessac, France, 33600
    • Hôpital Haut-Lévêque - CHU de Bordeaux

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: COPD; COPD according to GOLD 2019 but unrestricted to any level of bronchial reversibility established by the pulmonologist	Procedure: MRI; The procedure to study lung and heart MRI, performed on a 1.5T magnet (Siemens), without any injection or inhalation of contrast agent
Other: Asthma; asthma according to GINA 2019 but without any smoking restriction	Procedure: MRI; The procedure to study lung and heart MRI, performed on a 1.5T magnet (Siemens), without any injection or inhalation of contrast agent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	Day 30

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of age		Day 1
Assessment of sexe		Day 1
Assessment of tobacco consumption		Day 1
Assessment of disease duration		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	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	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	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	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	day 1
Determine of slow Vital Capacity (VC) during spirometry before and after bronchodilator		day 1
Determine of Total Lung Capacity (TLC) during spirometry before and after bronchodilator		day 1
Determine of Functional Residual Capacity (FRC) during spirometry before and after bronchodilator		day 1
Determine of Residual Volume (RV) during spirometry before and after bronchodilator		day 1
Determine of Carbon monoxide transfer capacity (TLCO)		day 1
Determine the value of blood heamoglobin		day 1
Determine the value of blood eosinophils		day 1
Determine the value of blood C-reactive protein		day 1
Determine the value of blood B-type natriuretic peptide		day 1
Determine the value of blood total IgE at		day 1
Determine the value of blood total IgE		day 1

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Investigators: Principal Investigator: Patrick BERGER, MD, PhD, University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2021
• Primary Completion (Estimated): March 30, 2024
• Study Completion (Estimated): March 30, 2024

Study Registration Dates

• First Submitted: April 2, 2020
• First Submitted That Met QC Criteria: April 8, 2020
• First Posted (Actual): April 10, 2020

Study Record Updates

• Last Update Posted (Actual): February 2, 2024
• Last Update Submitted That Met QC Criteria: February 1, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: MRI; lung; heart; multimodal; phenotypes
• Other Study ID Numbers: CHUBX 2018/37

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No