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

Asthma Copd Clinical Trial

— PIMABOD  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04341701
• Other study ID #: CHUBX 2018/37
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 5, 2021
• Est. completion date: March 30, 2024

Study information

• Verified date: February 2024
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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

.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: March 30, 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma Copd

Intervention

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

Locations

Country	Name	City	State
France	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

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

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