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

NCT04341701 | Active Not Recruiting

• 1 other identifier: CHUBX 2018/37
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 6

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.

Conditions

Asthma Copd

Keywords

MRI; multimodal; phenotypes; lung; heart

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (20)

• 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

  Day 1

Study Arms (2)

COPD

OTHER

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

Procedure: MRI

Asthma

OTHER

asthma according to GINA 2019 but without any smoking restriction

Procedure: MRI

Interventions

MRI 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; COPD

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (6)

Centre hospitalier de la Côte Basque

Bayonne, 64100, France

Location

Clinique Saint Augustin

Bordeaux, 33000, France

Location

Centre Médical Toki Eder

Cambo-les-Bains, 64250, France

Location

Hôpital Le Cluzeau - CHU de Limoges

Limoges, 87000, France

Location

Centre de Pneumologie Bordeaux Rive droite

Lormont, 33310, France

Location

Hôpital Haut-Lévêque - CHU de Bordeaux

Pessac, 33600, France

Location

Study Officials

• Patrick BERGER, MD, PhD

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: diagnostic imaging pilot study, exploratory, prospective, multi-center

Study Record Dates

• First Submitted: April 2, 2020
• First Posted: April 10, 2020
• Study Start: August 5, 2021
• Primary Completion: March 30, 2024
• Study Completion: March 30, 2024
• Last Updated: February 2, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (6)