Informations générales (source: ClinicalTrials.gov)
Evaluation of 3D Magnetic Resonance Spirometry: Comparison with Spirometry in Healthy Subjects and Patients with Respiratory Pathologies (asthma, COPD, Bilateral Lung Transplant) (gb-Spiro3D)
Interventional
N/A
Commissariat A L'energie Atomique (Voir sur ClinicalTrials)
mai 2023
mai 2028
05 avril 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL FOCH | ANTOINE ROUX | 05/05/2025 07:12:13 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CEA | Service Hospitalier Fréderic Joliot - 91401 - Orsay - France | MARTINS Bernadette | Contact (sur clinicalTrials) | |||
Critères
Tous
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)
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)