NCT05724745Recruiting

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

Source: ClinicalTrials.gov · Last updated 14 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry): Recruiting
Study type: Interventional
Enrollment: 240 (estimated)
First submitted: 15 Jan 2023
Start date: 26 May 2023
Primary completion date: May 2028
Lead sponsor: Commissariat A L'energie Atomique
Diseases: Asthma, COPD
NCT number: NCT05724745

What you commit to

Study type: Interventional
Planned participants: 240
From 26 May 2023 to the primary completion date, May 2028
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

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)

Age in the registry: 18 years to 90 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
CEA \| Service Hospitalier Fréderic Joliot Coordinator of this site? Confirm its status	Orsay	France	Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.