RecruitingNot ApplicableNCT05724745

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


Sponsor

Commissariat A L'energie Atomique

Enrollment

240 participants

Start Date

May 26, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 90 Years

Inclusion Criteria20

  • 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)

Interventions

DRUG3. 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_TEST4. 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.

DIAGNOSTIC_TEST1. Standard spirometry

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

DIAGNOSTIC_TEST2. 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.


Locations(1)

CEA | Service Hospitalier Fréderic Joliot

Orsay, France, France

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NCT05724745


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