gb-Spiro3D: Evaluation of 3D Magnetic Resonance Spirometry : Comparison to Spirometry in Healthy Subjects and Patients With Asthma and COPD

Sponsor

Commissariat A L'energie Atomique (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05724745

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Asthma COPD	Diagnostic Test: 1. Standard spirometry Diagnostic Test: 2. 3D dynamic lung MRI at UTE in prone and supine positions Drug: 3. Reversibility test with salbutamol Diagnostic Test: 4. 3D dynamic lung MRI at UTE in supine and prone position	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

75 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Feb 1, 2025

Anticipated Study Completion Date :

Dec 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Other: Healthy volunteers, Asthmatic patients and COPD patients This arm of the study is essential to establish nominal flow-volume maps of nominal flow-volume curves and to determine the dependence of normal breathing on gravity and response to a bronchodilator in order to evaluate the sensitivity and specificity of the technique for the known lung diseases asthma and COPD by comparing data from healthy the data from healthy subjects with those from sick subjects.	Diagnostic Test: 1. Standard spirometry Spirometry is performed in two positions (sitting and supine) and three types of breathing (spontaneous, forced and slow). Diagnostic Test: 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.

Arm

Intervention/Treatment

Other: Healthy volunteers, Asthmatic patients and COPD patients

This arm of the study is essential to establish nominal flow-volume maps of nominal flow-volume curves and to determine the dependence of normal breathing on gravity and response to a bronchodilator in order to evaluate the sensitivity and specificity of the technique for the known lung diseases asthma and COPD by comparing data from healthy the data from healthy subjects with those from sick subjects.

Diagnostic Test: 1. Standard spirometry

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

Diagnostic Test: 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.

Outcome Measures

Primary Outcome Measures

Correlation between (1) spontaneous expiratory volume in 1 s (SEV1) and tidal volume (TV) and (2) FEV1 and FVC [2 months]
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
Difference of expiratory volume in 1 s (SEV1) and tidal volume (TV) between the left and right lungs [2 months]
SEV1 and TV are extracted from the integrated flow-volume curves over the left and right lungs
Difference in expiratory volume in 1 s (SEV1) and tidal volume (TV) for the anterior-posterior, inferior-superior and medial-lateral lung regions [2 months]
SEV1 and TV are extracted from the integrated flow-volume curves over the anterior-posterior, inferior-superior and medial-lateral lung regions

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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