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

NCT05724745 | Recruiting

• 2 other identifiers: CEA 100-0612021-A00672-39
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma; COPD; BOS

Keywords

Lung disease; Asthma; COPD; Spirometry; MRI; 3D MR Spirometry

Outcome Measures

Primary Outcomes (3)

• Correlation between (1) spontaneous expiratory volume in 1 s (SEV1) and tidal volume (TV) and (2) FEV1 and FVC

  SEV1 and TV are extracted from the flow-volume curve calculated by integration over the whole lung of the local flow-volume curves obtained by 3D MR spirometry and FEV1 and FVC extracted from the flow-volume curve obtained by standard spirometry

  2 months

• Difference of expiratory volume in 1 s (SEV1) and tidal volume (TV) between the left and right lungs

  SEV1 and TV are extracted from the integrated flow-volume curves over the left and right lungs

  2 months

• Difference in expiratory volume in 1 s (SEV1) and tidal volume (TV) for the anterior-posterior, inferior-superior and medial-lateral lung regions

  SEV1 and TV are extracted from the integrated flow-volume curves over the anterior-posterior, inferior-superior and medial-lateral lung regions

  2 months

Study Arms (1)

Healthy volunteers, Asthmatic patients and COPD patients

OTHER

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.

Diagnostic Test: 1. Standard spirometry; Diagnostic Test: 2. 3D dynamic lung MRI at UTE in prone and supine positions; Drug: 3. Reversibility test with salbutamol; Diagnostic Test: 4. 3D dynamic lung MRI at UTE in supine and prone position

Interventions

1. Standard spirometry DIAGNOSTIC_TEST

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

Healthy volunteers, Asthmatic patients and COPD patients

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

Healthy volunteers, Asthmatic patients and COPD patients

3. Reversibility test with salbutamol 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).

Healthy volunteers, Asthmatic patients and COPD patients

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

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

Healthy volunteers, Asthmatic patients and COPD patients

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 significant bronchial stenosis (having required endoscopic endoscopic treatment)

Sponsors & Collaborators

• Commissariat A L'energie Atomique: lead

Study Sites (1)

CEA | Service Hospitalier Fréderic Joliot

Orsay, France, 91401, France

RECRUITING

MeSH Terms

Conditions

Asthma; Pulmonary Disease, Chronic Obstructive; Lung Diseases

Interventions

Prone Position; Supine Position; Albuterol

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Central Study Contacts

MARTINS Bernadette

CONTACT

+33169087460; bernadette.martins@cea.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 15, 2023
• First Posted: February 13, 2023
• Study Start: May 26, 2023
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: February 14, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)