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

Primary Purpose

Asthma, COPD

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
1. Standard spirometry
2. 3D dynamic lung MRI at UTE in prone and supine positions
3. Reversibility test with salbutamol
4. 3D dynamic lung MRI at UTE in supine and prone position
Sponsored by
Commissariat A L'energie Atomique
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Asthma focused on measuring Lung disease, Asthma, COPD, Spirometry, MRI, 3D MR Spirometry

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • CEA | Service Hospitalier Fréderic Joliot

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Healthy volunteers, Asthmatic patients and COPD patients

Arm Description

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.

Outcomes

Primary Outcome Measures

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
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
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

Secondary Outcome Measures

Full Information

First Posted
January 15, 2023
Last Updated
February 2, 2023
Sponsor
Commissariat A L'energie Atomique
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1. Study Identification

Unique Protocol Identification Number
NCT05724745
Brief Title
Evaluation of 3D Magnetic Resonance Spirometry : Comparison to Spirometry in Healthy Subjects and Patients With Asthma and COPD
Acronym
gb-Spiro3D
Official Title
Evaluation of 3D Magnetic Resonance Spirometry : Comparison to Spirometry in Healthy Subjects and Patients With Asthma and COPD
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 2023 (Anticipated)
Primary Completion Date
February 2025 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Commissariat A L'energie Atomique

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, COPD
Keywords
Lung disease, Asthma, COPD, Spirometry, MRI, 3D MR Spirometry

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Healthy volunteers, Asthmatic patients and COPD patients
Arm Type
Other
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
1. Standard spirometry
Intervention Description
Spirometry is performed in two positions (sitting and supine) and three types of breathing (spontaneous, forced and slow).
Intervention Type
Diagnostic Test
Intervention Name(s)
2. 3D dynamic lung MRI at UTE in prone and supine positions
Intervention Description
Dynamic lung MRI is performed for 3D MR spirometry while the subject is lying prone and supine before a reversibility test with salbutamol.
Intervention Type
Drug
Intervention Name(s)
3. Reversibility test with salbutamol
Intervention Description
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).
Intervention Type
Diagnostic Test
Intervention Name(s)
4. 3D dynamic lung MRI at UTE in supine and prone position
Intervention Description
Dynamic lung MRI is performed for 3D MR spirometry while the subject is lying prone and supine after the bronchodilatator's administration.
Primary Outcome Measure Information:
Title
Correlation between (1) spontaneous expiratory volume in 1 s (SEV1) and tidal volume (TV) and (2) FEV1 and FVC
Description
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
Time Frame
2 months
Title
Difference of expiratory volume in 1 s (SEV1) and tidal volume (TV) between the left and right lungs
Description
SEV1 and TV are extracted from the integrated flow-volume curves over the left and right lungs
Time Frame
2 months
Title
Difference in expiratory volume in 1 s (SEV1) and tidal volume (TV) for the anterior-posterior, inferior-superior and medial-lateral lung regions
Description
SEV1 and TV are extracted from the integrated flow-volume curves over the anterior-posterior, inferior-superior and medial-lateral lung regions
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
MARTINS Bernadette
Phone
+33169087460
Email
bernadette.martins@cea.fr
Facility Information:
Facility Name
CEA | Service Hospitalier Fréderic Joliot
City
Orsay
ZIP/Postal Code
91401
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MARTINS Bernadette
Phone
+33169087460
Email
bernadette.martins@cea.fr

12. IPD Sharing Statement

Learn more about this trial

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

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