Evaluation of 3D Magnetic Resonance Spirometry: Comparison with Spirometry in Healthy Subjects and Patients with Respiratory Pathologies (asthma, COPD, Bilateral Lung Transplant)

NCT ID: NCT05724745

Last Updated: 2025-02-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-26
• Study Completion Date: 2028-05-31

Brief Summary

Spirometry is now the gold standard technique for assessing lung function in humans. From the shape of a flow-volume curve measured while the patient, trained by the practitioner, performs forced breaths, the forced vital capacity (FVC) and the forced expiratory volume in one second (FEV1) can be deduced and the pulmonologist is able to detect and characterize respiratory diseases as well as to evaluate current treatments. This technique is non-invasive and simple. It is widely available, robust, reproducible and sensitive to intervention. However, it requires proactive cooperation from the patient and only measures global pulmonary ventilation, without locoregional information.

An innovative strategy and an original study framework have been developed in the BioMaps laboratory to establish local maps of flow-volume curves across the lung and to jointly analyze ventilatory function and mechanical behavior at any point in the lung: 3D magnetic resonance spirometry. As respiratory mechanics fundamentally supports ventilatory function, this technique should open a new avenue to non-invasively explore lung function while providing a better diagnosis of regional lung diseases.

Detailed Description

Main objectiif / Evaluate the concordance of the results provided by 3D spirometry using compared with those obtained by spirometry in four populations: healthy four populations: healthy volunteers, asthma patients, patients with chronic obstructive pulmonary, chronic obstructive pulmonary disease (COPD) and lung transplant patients. with and without bronchiolitis obliterans syndrome (BOS). obliterative bronchiolitis syndrome (BOS).

Conditions

Asthma; COPD; BOS

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Healthy volunteers, Asthmatic patients and COPD patients

This arm of the study is essential to establish nominal flow-volume maps of nominal flow-volume curves and to determine the dependence of normal breathing on gravity and response to a bronchodilator in order to evaluate the sensitivity and specificity of the technique for the known lung diseases asthma and COPD by comparing data from healthy the data from healthy subjects with those from sick subjects.

Group Type: OTHER

1. Standard spirometry

Intervention Type: DIAGNOSTIC_TEST

Spirometry is performed in two positions (sitting and supine) and three types of breathing (spontaneous, forced and slow).

2. 3D dynamic lung MRI at UTE in prone and supine positions

Intervention Type: DIAGNOSTIC_TEST

Dynamic lung MRI is performed for 3D MR spirometry while the subject is lying prone and supine before a reversibility test with salbutamol.

3. Reversibility test with salbutamol

Intervention Type: DRUG

Reversibility test with salbutamol administered using a pressurized metered dose bottle and an inhalation chamber at a dosage of 100 μg, 4 times (i.e., 400 μg in total).

4. 3D dynamic lung MRI at UTE in supine and prone position

Intervention Type: DIAGNOSTIC_TEST

Dynamic lung MRI is performed for 3D MR spirometry while the subject is lying prone and supine after the bronchodilatator's administration.

Interventions

1. Standard spirometry

Spirometry is performed in two positions (sitting and supine) and three types of breathing (spontaneous, forced and slow).

Intervention Type: DIAGNOSTIC_TEST

2. 3D dynamic lung MRI at UTE in prone and supine positions

Dynamic lung MRI is performed for 3D MR spirometry while the subject is lying prone and supine before a reversibility test with salbutamol.

Intervention Type: DIAGNOSTIC_TEST

3. Reversibility test with salbutamol

Reversibility test with salbutamol administered using a pressurized metered dose bottle and an inhalation chamber at a dosage of 100 μg, 4 times (i.e., 400 μg in total).

Intervention Type: DRUG

4. 3D dynamic lung MRI at UTE in supine and prone position

Dynamic lung MRI is performed for 3D MR spirometry while the subject is lying prone and supine after the bronchodilatator's administration.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Ability to understand the nature and objectives of the study
• Ability to remain immobile in an MRI scanner in supine position for the entire duration of the acquisitions
• Age: 18-45 years
• No known and diagnosed pulmonary pathology such as respiratory insufficiency, COPD, asthma or cancer
• Ability to remain motionless in an MRI scanner in a prone position for a total of 50 min.
• Age: 18-80 years
• Asthma of varying degrees of severity, depending on inhalation required to achieve control:
• Diagnosis of asthma classified as moderate according to the Global initiative for asthma (GINA) guidelines for at least 6 months
• Diagnosis of asthma classified as severe according to the Global initiative for asthma (GINA) guidelines for at least 6 months months with initiation of biotherapy planned by their pulmonologist
• Age: 40-80 years
• COPD of varying degrees of severity:
• Diagnosis of COPD classified as moderate according to the Global initiative for chronic obstructive lung disease guidelines (GOLD 2: VEMS = 50-79%)
• Age: 18-90 years
• Irreversible FEV1 < 80% of baseline with FEV1/FVC ratio FEV1/FVC < 0.7
• Absence of visible parenchymal opacity on CT scan (non inclusion of mixed RAS/CLAD)
• Absence of significant bronchial stenosis (having required endoscopic endoscopic treatment)
• Age: 18-90 years
• FEV1 > 90% baseline for more than 24 months after the date of date of lung transplantation
• Absence of significant bronchial stenosis (requiring endoscopic endoscopic treatment)
• Absence of diaphragmatic impairment (established by sniff test under fluoroscopy or diaphragmatic ultrasound)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Commissariat A L'energie Atomique

OTHER_GOV

Sponsor Role: lead

Responsible Party

Vincent LEBON

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

CEA | Service Hospitalier Fréderic Joliot

Orsay, France, France

Site Status: RECRUITING

Countries

France

Central Contacts

MARTINS Bernadette

Role: CONTACT

bernadette.martins@cea.fr

+33169087460

Facility Contacts

MARTINS Bernadette

Role: primary

bernadette.martins@cea.fr

+33169087460

Other Identifiers

2021-A00672-39

Identifier Type: OTHER

Identifier Source: secondary_id

CEA 100-061

Identifier Type: -

Identifier Source: org_study_id