Evaluating 3D Magnetic Resonance Spirometry for Lung Function Assessment

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

This study is testing a new 3D lung scan to see how it compares to regular lung tests in healthy people and those with asthma, COPD, or who have had a lung transplant.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 240 (estimated)
• Ages: 18 Years to 90 Years
• Sex: All
• Sponsor: Commissariat A L'energie Atomique (other gov)
• Locations: 1 site (Orsay, France)
• Trial ID: NCT05724745 on ClinicalTrials.gov

What this trial studies

This study aims to compare the results of 3D magnetic resonance spirometry with traditional spirometry in four groups: healthy volunteers, asthma patients, individuals with chronic obstructive pulmonary disease (COPD), and lung transplant patients. The innovative 3D spirometry technique allows for detailed local mapping of lung function, providing insights into ventilatory performance and mechanical behavior at specific lung regions. Participants will undergo both standard spirometry and 3D dynamic lung MRI in different positions to assess the concordance of results across these populations.

Who should consider this trial

Good fit: Ideal candidates include healthy adults aged 18-45 and patients aged 18-80 with asthma, COPD, or lung transplant history.

Not a fit: Patients with severe respiratory conditions that prevent them from remaining still in an MRI scanner may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the accuracy of lung function assessments, leading to better diagnosis and management of respiratory diseases.

How similar studies have performed: While traditional spirometry is well-established, the use of 3D magnetic resonance spirometry is a novel approach that has not been widely tested in clinical settings.

Eligibility criteria

Inclusion Criteria:

Generic 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
* Ability to give free and informed written consent Specific inclusion criteria for healthy volunteers
* 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.
* Non-smoker and non-smoker Specific inclusion criteria for asthma patients
* 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
* Non-smoker and non-vapourist Specific inclusion criteria for COPD patients
* 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%)
* Diagnosis of COPD classified as severe according to the guidelines for chronic obstructive lung disease (GOLD 3: VEMS = 30-49%) Specific inclusion criteria for patients with bilateral lung transplants with BOS
* 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)
* No diaphragmatic involvement (established by sniff test under fluoroscopy fluoroscopy or diaphragmatic ultrasound) Specific inclusion criteria for patients with bilateral lung transplants without BOS
* 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)

Where this trial is running

Orsay, France

• CEA | Service Hospitalier Fréderic Joliot — Orsay, France, France (RECRUITING)

Study contacts

• Study coordinator: MARTINS Bernadette

Conditions: Asthma, COPD, BOS, Lung disease, Spirometry, MRI, 3D MR Spirometry