Evaluation of 3D Magnetic Resonance Spirometry : Comparison to Spirometry in Healthy Subjects and Patients With Asthma and COPD

Asthma Clinical Trial

— gb-Spiro3D  

Official title:

Evaluation of 3D Magnetic Resonance Spirometry : Comparison to Spirometry in Healthy Subjects and Patients With Asthma and COPD

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05724745
• Other study ID #: CEA 100-061
• Secondary ID: 2021-A00672-39
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2023
• Est. completion date: December 2026

Study information

• Verified date: February 2023
• Source: Commissariat A L'energie Atomique
• Contact: MARTINS Bernadette
• Phone: +33169087460
• Email: bernadette.martins[@]cea.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 75
• Est. completion date: December 2026
• Est. primary completion date: February 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Ability to understand the nature and objectives of the study and to appreciate the risks involved

• Ability to stand in an MRI machine without moving in supine and prone positions

• Informed and written consent

For healthy subjects:

• No known diagnosed lung disease such as respiratory failure, COPD, asthma or cancer

• Non-smoker

For asthmatic subjects:

• Asthma of varying degrees of severity

• Non-smoker For COPD subjects

• COPD with different degrees of severity

Exclusion Criteria:

• Refusal to sign consent

• Any pathology or condition (active tumor, pregnancy, breastfeeding) that the investigators believe may compromise the safety of the subject or the objectives of the study

• Persons who have had a symptomatic Covid-19 infection

• Contraindication to performing an MRI examination (claustrophobia, metallic prosthesis, pacemaker, metallic prosthetic heart valve, cochlear implants, vascular clips, insulin pump)

• Contraindication to spirometry testing (acute myocardial infarction, severe systemic hypotension or hypertension, significant atrial/ventricular arrhythmia, uncompensated heart failure, uncontrolled pulmonary hypertension, pulmonary embolism, history of syncope, cerebral aneurysm, brain surgery (4 weeks), recent concussion, eye surgery (1 week), sinus or middle ear surgery, pneumothorax, thoracic or abdominal surgery (4 weeks)

• Contraindication to the administration of a short-acting bronchodilator (history of hypersensitivity to the active substance or to one of the excipients, history of intolerance to the product such as the occurrence of cough or bronchospasm after inhalation, pregnancy, thyrotoxicosis, coronary artery disease, hypertrophic obstructive cardiomyopathy, hypertension, tachyarrhythmia, diabetes, association with digitalis, MAO inhibitors, tricyclic antidepressants, known hypokalemia or hypokalemic drugs: diuretics, laxatives, steroids, xanthine).

• Non-membership in a social security system

• Protected persons (guardianship, curatorship) For healthy subjects and asthmatic subjects

• Tobacco history of more than 5 packs/year

Related Conditions & MeSH terms

• Asthma
• COPD

Intervention

Diagnostic Test:
• 1. Standard spirometry
Spirometry is performed in two positions (sitting and supine) and three types of breathing (spontaneous, forced and slow).
• 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.

Locations

Country	Name	City	State
France	CEA | Service Hospitalier Fréderic Joliot	Orsay

Sponsors (1)

Lead Sponsor	Collaborator
Commissariat A L'energie Atomique

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between (1) spontaneous expiratory volume in 1 s (SEV1) and tidal volume (TV) and (2) FEV1 and FVC	SEV1 and TV are extracted from the flow-volume curve calculated by integration over the whole lung of the local flow-volume curves obtained by 3D MR spirometry and FEV1 and FVC extracted from the flow-volume curve obtained by standard spirometry	2 months
Primary	Difference of expiratory volume in 1 s (SEV1) and tidal volume (TV) between the left and right lungs	SEV1 and TV are extracted from the integrated flow-volume curves over the left and right lungs	2 months
Primary	Difference in expiratory volume in 1 s (SEV1) and tidal volume (TV) for the anterior-posterior, inferior-superior and medial-lateral lung regions	SEV1 and TV are extracted from the integrated flow-volume curves over the anterior-posterior, inferior-superior and medial-lateral lung regions	2 months