Asthmagb-Spiro3DNCT05724745
Evaluation of 3D Magnetic Resonance Spirometry: Comparison with Spirometry in Healthy Subjects and Patients with Respiratory Pathologies (asthma, COPD, Bilateral Lung Transplant)
A study testing 1. Standard spirometry, 2. 3D dynamic lung MRI at UTE in prone and supine positions and 3. Reversibility test with salbutamol in people with Asthma and COPD, run by Commissariat A L'energie Atomique at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- What is being tested?
- 1. Standard spirometry, 2. 3D dynamic lung MRI at UTE in prone and supine positions and 3. Reversibility test with salbutamol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteFrance
- Study dates
- 26 May 2023to May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 26Show fewer
- 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)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CEA | Service Hospitalier Fréderic Joliot
Orsay, France, 91401
MARTINS Bernadette, +33169087460, bernadette.martins@cea.fr
About this study
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.
Read the detailed description
Main objectiif / Evaluate the concordance of the results provided by 3D spirometry using compared with those obtained by spirometry in four populations: healthy four populations: healthy volunteers, asthma patients, patients with chronic obstructive pulmonary, chronic obstructive pulmonary disease (COPD) and lung transplant patients. with and without bronchiolitis obliterans syndrome (BOS). obliterative bronchiolitis syndrome (BOS).
- Being tested
- 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
- Keywords
- Lung disease, Asthma, COPD, Spirometry, MRI, 3D MR Spirometry
- Medical subject headings
- Asthma, Pulmonary Disease, Chronic Obstructive, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1. Standard spirometryDiagnostic test
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 positionsDiagnostic test
Dynamic lung MRI is performed for 3D MR spirometry while the subject is lying prone and supine before a reversibility test with salbutamol.
3. Reversibility test with salbutamolDrug
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).
4. 3D dynamic lung MRI at UTE in supine and prone positionDiagnostic test
Dynamic lung MRI is performed for 3D MR spirometry while the subject is lying prone and supine after the bronchodilatator's administration.
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers, Asthmatic patients and COPD patients | Other | 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 months
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
Measured: 2 months
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
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start26 May 2023
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Commissariat A L'energie Atomique
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Vincent LEBON, Commissariat A L'energie Atomique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05724745
- Sponsor's protocol ID
- CEA 100-061
- Other IDs
- 2021-A00672-39
- Acronym
- gb-Spiro3D
- Status last verified
- Feb 2025
- First submitted
- 15 Jan 2023
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of 3D Magnetic Resonance Spirometry: Comparison with Spirometry in Healthy Subjects and Patients with Respiratory Pathologies (asthma, COPD, Bilateral Lung Transplant)
- ClinicalTrials.gov ID
- NCT05724745
- Acronym / sponsor ID
- gb-Spiro3D / CEA 100-061
- Keywords
- Lung disease, Asthma, COPD, Spirometry, MRI, 3D MR Spirometry
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Commissariat A L'energie AtomiqueOther government
- Study start
- 26 May 2023 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 13 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Main objectiif / Evaluate the concordance of the results provided by 3D spirometry using compared with those obtained by spirometry in four populations: healthy four populations: healthy volunteers, asthma patients, patients with chronic obstructive pulmonary, chronic obstructive pulmonary disease (COPD) and lung transplant patients. with and without bronchiolitis obliterans syndrome (BOS). obliterative bronchiolitis syndrome (BOS).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers, Asthmatic patients and COPD patients | Other | 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 positionThis 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1. Standard spirometrySpirometry is performed in two positions (sitting and supine) and three types of breathing (spontaneous, forced and slow). | Diagnostic test | Healthy volunteers, Asthmatic patients and COPD patients |
| 2. 3D dynamic lung MRI at UTE in prone and supine positionsDynamic lung MRI is performed for 3D MR spirometry while the subject is lying prone and supine before a reversibility test with salbutamol. | Diagnostic test | Healthy volunteers, Asthmatic patients and COPD patients |
| 3. Reversibility test with salbutamolReversibility 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). | Drug | Healthy volunteers, Asthmatic patients and COPD patients |
| 4. 3D dynamic lung MRI at UTE in supine and prone positionDynamic lung MRI is performed for 3D MR spirometry while the subject is lying prone and supine after the bronchodilatator's administration. | Diagnostic test | Healthy volunteers, Asthmatic patients and COPD patients |
Primary outcome
Correlation between (1) spontaneous expiratory volume in 1 s (SEV1) and tidal volume (TV) and (2) FEV1 and FVC
Time frame: 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
Time frame: 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
Time frame: 2 months
SEV1 and TV are extracted from the integrated flow-volume curves over the anterior-posterior, inferior-superior and medial-lateral lung regions
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1. Standard spirometry, 2. 3D dynamic lung MRI at UTE in prone and supine positions and 3. Reversibility test with salbutamol in people with Asthma and COPD, run by Commissariat A L'energie Atomique at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 26 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact MARTINS Bernadette (+33169087460, bernadette.martins@cea.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between (1) spontaneous expiratory volume in 1 s (SEV1) and tidal volume (TV) and (2) FEV1 and FVC (time frame: 2 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2025.