NCT05724745

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Commissariat A L'energie Atomique · Other Government
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	1. Standard spirometry	Spirometry is performed in two positions (sitting and supine) and three types of breathing (spontaneous, forced and slow).
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.
DRUG	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).
DIAGNOSTIC_TEST	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.

Timeline

• Start date: 2023-05-26
• Primary completion: 2028-05-01
• Completion: 2028-05-01
• First posted: 2023-02-13
• Last updated: 2025-02-14

Locations

1 site across 1 country: France