Bronchiolitis ObliteransIRM-ANCT04080232
Study of Pulmonary MRI for the Diagnosis of Bronchiolitis Obliterans Syndrome After Allogeneic Stem Cell Transplantation
A study testing lung MRI in people with Bronchiolitis Obliterans, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
Bronchiolitis Obliterans Syndrome (BOS) is a major complication of Hematopoietic Stem cell Transplantation (HSCT) occurring in the context of chronic GVHD and associated with a poor prognosis. The diagnosis of BOS is based on functional (Pulmonary Functional Tests) and morphological criteria (chest CT-scan). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bronchiolitis Obliterans
- What is being tested?
- lung MRI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteFrance
- Study dates
- 6 Feb 2020to 11 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient ≥ 18 yo ;
- Patient who underwent an allogeneic stem cell transplantation (SCT)
- > 3 months post-SCT
- With evidence of
- respiratory symptoms, and/or
- Pathological PFTs defined by : obstructive syndrome (FEV1 :vital capacity/CVF < 0.7), FEV1 < 0.75 of pre-SCT values, residual volume > 120%, and/or ;
- Altered PFTs consistent with 0p stage described in lung transplantation BOS: FEV1 decline ≥ 10 % and/or FEF25-75 decline ≥ 25% compared to pre-SCT PFTs, and/or ;
- Abnormal chest CT-scan with findings consistent with BOS: evidence of air trapping on expiratory CT-scan, bronchiectasis, and/or airway thickening.
Who cannot join
- Contraindication for MRI ;
- Contraindication of oxygen administration ;
- Decompensation of altered respiratory function ;
- Acute respiratory infection (bacterial, fungal or viral) documented in the last 6 weeks ;
Trial locations and contacts
1 site in 1 country.
About this study
Bronchiolitis Obliterans Syndrome (BOS) is a major complication of Hematopoietic Stem cell Transplantation (HSCT) occurring in the context of chronic GVHD and associated with a poor prognosis. The diagnosis of BOS is based on functional (Pulmonary Functional Tests) and morphological criteria (chest CT-scan). Early diagnosis of BOS represents an unmet need and would facilitate early therapeutic interventions. Lung MRI has been recently developed with new sequences facilitating morphological and functional lung analysis in various inflammatory contexts. The goal of this study is to compare the morphological performances of chest CT-scan and MRI
Read the detailed description
Patients undergoing allogeneic stem cell transplantation may develop non-infectious respiratory complication related to chronic graft versus host disease and called bronchiolitis obliterans syndrome (BOS). The occurrence of BOS is associated with a decreased survival reaching 13% at 5 years (Dudek et al, BBMT 2003). Thus, screening and diagnosis of BOS appear as a priority of post-transplant patients monitoring, in order to begin early therapy if needed. To this end, patients undergo systematic and regular screening using pulmonary function tests (PFTs). In case of abnormal PFTs, tests are completed the screening of respiratory infections and chest computed tomographic scan (CT-scan) is performed. A report from the National Institute of Health described the following criteria required for the diagnosis of BOS : FEV1/vital capacity < 0.7, FEV1 < 75% or a decline >/= 10% from baseline, residual volume > 120%, absence of documented infection, and the presence of CT-scan signs suggestive of BOS : air trapping by expiratory CT or small airway thickening or bronchiectasis.
BOS severity depends on the development of fibrotic and fixed damages, poorly responding to therapies. New tools are needed in order to favor early BOS diagnosis.
A recent study from our center showed that repeated CT-scans in stem cell transplant patients is associated with increased risk of neoplasia. In addition, recent studies from our center evaluated the use of pulmonary MRI providing good performance without X-ray exposure (Dournes G et al, Radiology 2015 et Dournes G et al, Eur Radiol 2015).
More recently, Renne et al (Radiology 2015) studied the performance of pulmonary MRI coupled with oxygen transfer analysis for the diagnosis of chronic lung allograft dysfunction. This study showed altered imaging parameters in patients developing BOS, including patients with early BOS stage (0p stage).
As pathogenic mechanisms seem to be shared between post-stem cell transplant and post-lung transplant BOS, we hypothesize that pulmonary MRI with oxygen transfer analysis and ultra short echo time may represent a non-invasive, non-irradiating and sensitive research tool for the detection and quantification of pulmonary lesions in patients screened for post-stem cell transplant BOS.
Thus, 20 patients who underwent allogeneic stem cell transplantation and show abnormal respiratory function over a 2 year period study are expected. They will be included according to the following criteria : age > 18 yo, > 3 months post-transplant, absence of documented pulmonary infection, or with a minimum of 6 weeks after a documented pulmonary infection, and the following BOS criteria : abnormal PFTs (FEV1/VC < 0.7, FEV1 < 0.75, residual volume < 120% of expected value) and/or chest CT-scan showing air trapping or small airway thickening. Similarly to lung transplant criteria, stage 0p BOS defined according to FEF25-75 values (Estenne et al, JHLT 2002), for which pulmonary MRI with oxygen transfer may guide to early BOS diagnosis, will be added.
Patients who give their consent will perform a pulmonary MRI, in the absence of contraindication, using different sequences to evaluate morphologic and functional performances of pulmonary MRI. We will compare CT-scan and MRI performances using blinded analysis from two radiologists.
- Conditions
- Bronchiolitis Obliterans
- Being tested
- lung MRI
- Keywords
- lung MRI performance, UTE, quantification, oxygen transfer, Bronchiolitis Obliterans syndrome, allogeneic stem cell transplantation
- Medical subject headings
- Bronchiolitis Obliterans, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lung MRIDevice
lung MRI (1.5T Siemens Aera) using the following sequences: 3D Fast gradient-echo pulse sequences with ultra-short echo time (UTE), acquisitions at end-inspiration breath hold, end-expiration breath hold, and free-breathing using an echonavigator positioned on the diaphragm, acquisitions using routine pulse sequences (SSFP, T2FSE) and the administration of oxygen during the MRI: O2 will be administered at 15L/min during 6 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Lung MRI | Experimental | lung MRI concordance as compared to chest CT-scan for the description of morphological abnormalities necessary for the diagnosis of BOS after HSCT. It will be evaluated using lung MRI performed after inclusion (D0) using a standardized procedure Receives: Device: lung MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
lung MRI concordance as compared to chest CT-scan
lung MRI concordance as compared to chest CT-scan for the description of morphological abnormalities necessary for the diagnosis of BOS after HSCT. It will be evaluated using lung MRI performed after inclusion (Baseline) using a standardized procedure. The agreement between MRI and chest CT-scan for the presence or absence of the following features, will be measured at the segmental level: airway thickening, bronchiectasis, air trapping.
Measured: Baseline
Secondary outcomes (14)
Bhalla Score precision in morphological MRI
Measure of Bhalla Score precision in morphological MRI for the diagnosis of post-transplant BOS
Measured: Baseline
Bhalla Score in CT scan
Bhalla Score in CT scan
Measured: Baseline
oxygen transfer capacity
Measure of oxygen transfer capacity (percentage of intra-pulmonary signal variation before and after inhalation of oxygen);
Measured: Baseline
Force Expiratory Volume
Force Expiratory Volume (FEV, l)
Measured: Baseline
FEV1/VC
FEV1/VC (Tiffeneau),
Measured: Baseline
Residual volume
Residual volume (l)
Measured: Baseline
total lung capacity
Total lung capacity (l)
Measured: Baseline
BOS stages
BOS stages (0 : FEV1 > 90%, and FEF25-75 > 75% from baseline; 0p : 10-19% decrease in FEV1, and/or by a >/= 25% decrease in FEF 25-75 from baseline; 1: FEV1 60-79% ; 2: FEV1 40-59% ; 3: FEV1</= 39)
Measured: Baseline
intra-observer repeatability of the Bhalla score in CT scan
Intraclass coefficient and Bland-Altman's test
Measured: Baseline
intra-observer repeatability of the Bhalla score in MRI
Intraclass coefficient and Bland-Altman's test
Measured: Baseline
intra-observer repeatability of the measure of oxygen transfer capacity
Intraclass coefficient and Bland-Altman's test
Measured: Baseline
inter-observer reproducibility of the Bhalla score in CT scan
Intraclass coefficient and Bland-Altman's test
Measured: Baseline
inter-observer reproducibility of the Bhalla score in MRI
Intraclass coefficient and Bland-Altman's test
Measured: Baseline
inter-observer reproducibility of the measure of oxygen transfer capacity
Intraclass coefficient and Bland-Altman's test
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start6 Feb 2020
- Primary completion11 May 2023
- Study completion11 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchiolitis ObliteransStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- SFGM-TC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04080232
- Sponsor's protocol ID
- CHUBX 2017/05
- Other IDs
- 2017-A01873-50
- Acronym
- IRM-A
- Status last verified
- Nov 2024
- First submitted
- 4 Jul 2019
- Last updated
- 1 Jun 2026
- 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 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Pulmonary MRI for the Diagnosis of Bronchiolitis Obliterans Syndrome After Allogeneic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT04080232
- Acronym / sponsor ID
- IRM-A / CHUBX 2017/05
- Conditions
- Bronchiolitis Obliterans
- Keywords
- lung MRI performance, UTE, quantification, oxygen transfer, Bronchiolitis Obliterans syndrome, allogeneic stem cell transplantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- SFGM-TC
- Study start
- 6 Feb 2020 (actual)
- Primary completion
- 11 May 2023 (actual)
- Study completion
- 11 May 2023 (actual)
- First posted
- 6 Sep 2019 (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.
Bronchiolitis Obliterans Syndrome (BOS) is a major complication of Hematopoietic Stem cell Transplantation (HSCT) occurring in the context of chronic GVHD and associated with a poor prognosis. The diagnosis of BOS is based on functional (Pulmonary Functional Tests) and morphological criteria (chest CT-scan). Early diagnosis of BOS represents an unmet need and would facilitate early therapeutic interventions. Lung MRI has been recently developed with new sequences facilitating morphological and functional lung analysis in various inflammatory contexts. The goal of this study is to compare the morphological performances of chest CT-scan and MRI
Detailed description
Patients undergoing allogeneic stem cell transplantation may develop non-infectious respiratory complication related to chronic graft versus host disease and called bronchiolitis obliterans syndrome (BOS). The occurrence of BOS is associated with a decreased survival reaching 13% at 5 years (Dudek et al, BBMT 2003). Thus, screening and diagnosis of BOS appear as a priority of post-transplant patients monitoring, in order to begin early therapy if needed. To this end, patients undergo systematic and regular screening using pulmonary function tests (PFTs). In case of abnormal PFTs, tests are completed the screening of respiratory infections and chest computed tomographic scan (CT-scan) is performed. A report from the National Institute of Health described the following criteria required for the diagnosis of BOS : FEV1/vital capacity < 0.7, FEV1 < 75% or a decline >/= 10% from baseline, residual volume > 120%, absence of documented infection, and the presence of CT-scan signs suggestive of BOS : air trapping by expiratory CT or small airway thickening or bronchiectasis.
BOS severity depends on the development of fibrotic and fixed damages, poorly responding to therapies. New tools are needed in order to favor early BOS diagnosis.
A recent study from our center showed that repeated CT-scans in stem cell transplant patients is associated with increased risk of neoplasia. In addition, recent studies from our center evaluated the use of pulmonary MRI providing good performance without X-ray exposure (Dournes G et al, Radiology 2015 et Dournes G et al, Eur Radiol 2015).
More recently, Renne et al (Radiology 2015) studied the performance of pulmonary MRI coupled with oxygen transfer analysis for the diagnosis of chronic lung allograft dysfunction. This study showed altered imaging parameters in patients developing BOS, including patients with early BOS stage (0p stage).
As pathogenic mechanisms seem to be shared between post-stem cell transplant and post-lung transplant BOS, we hypothesize that pulmonary MRI with oxygen transfer analysis and ultra short echo time may represent a non-invasive, non-irradiating and sensitive research tool for the detection and quantification of pulmonary lesions in patients screened for post-stem cell transplant BOS.
Thus, 20 patients who underwent allogeneic stem cell transplantation and show abnormal respiratory function over a 2 year period study are expected. They will be included according to the following criteria : age > 18 yo, > 3 months post-transplant, absence of documented pulmonary infection, or with a minimum of 6 weeks after a documented pulmonary infection, and the following BOS criteria : abnormal PFTs (FEV1/VC < 0.7, FEV1 < 0.75, residual volume < 120% of expected value) and/or chest CT-scan showing air trapping or small airway thickening. Similarly to lung transplant criteria, stage 0p BOS defined according to FEF25-75 values (Estenne et al, JHLT 2002), for which pulmonary MRI with oxygen transfer may guide to early BOS diagnosis, will be added.
Patients who give their consent will perform a pulmonary MRI, in the absence of contraindication, using different sequences to evaluate morphologic and functional performances of pulmonary MRI. We will compare CT-scan and MRI performances using blinded analysis from two radiologists.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lung MRI | Experimental | Device: lung MRIlung MRI concordance as compared to chest CT-scan for the description of morphological abnormalities necessary for the diagnosis of BOS after HSCT. It will be evaluated using lung MRI performed after inclusion (D0) using a standardized procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient ≥ 18 yo ;
- Patient who underwent an allogeneic stem cell transplantation (SCT)
- > 3 months post-SCT
- With evidence of
Key exclusion criteria (4 listed)
- Contraindication for MRI ;
- Contraindication of oxygen administration ;
- Decompensation of altered respiratory function ;
- Acute respiratory infection (bacterial, fungal or viral) documented in the last 6 weeks ;
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 |
|---|---|---|
| lung MRIlung MRI (1.5T Siemens Aera) using the following sequences: 3D Fast gradient-echo pulse sequences with ultra-short echo time (UTE), acquisitions at end-inspiration breath hold, end-expiration breath hold, and free-breathing using an echonavigator positioned on the diaphragm, acquisitions using routine pulse sequences (SSFP, T2FSE) and the administration of oxygen during the MRI: O2 will be administered at 15L/min during 6 minutes. | Device | Lung MRI |
Primary outcome
lung MRI concordance as compared to chest CT-scan
Time frame: Baseline
lung MRI concordance as compared to chest CT-scan for the description of morphological abnormalities necessary for the diagnosis of BOS after HSCT. It will be evaluated using lung MRI performed after inclusion (Baseline) using a standardized procedure. The agreement between MRI and chest CT-scan for the presence or absence of the following features, will be measured at the segmental level: airway thickening, bronchiectasis, air trapping.
14 secondary outcomes
Bhalla Score precision in morphological MRI
Time frame: Baseline
Bhalla Score in CT scan
Time frame: Baseline
oxygen transfer capacity
Time frame: Baseline
Force Expiratory Volume
Time frame: Baseline
FEV1/VC
Time frame: Baseline
Residual volume
Time frame: Baseline
total lung capacity
Time frame: Baseline
BOS stages
Time frame: Baseline
intra-observer repeatability of the Bhalla score in CT scan
Time frame: Baseline
intra-observer repeatability of the Bhalla score in MRI
Time frame: Baseline
intra-observer repeatability of the measure of oxygen transfer capacity
Time frame: Baseline
inter-observer reproducibility of the Bhalla score in CT scan
Time frame: Baseline
inter-observer reproducibility of the Bhalla score in MRI
Time frame: Baseline
inter-observer reproducibility of the measure of oxygen transfer capacity
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lung MRI in people with Bronchiolitis Obliterans, run by University Hospital, Bordeaux 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 8 inclusion and 4 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: finished, as of the sponsor's last update on 1 Jun 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
lung MRI concordance as compared to chest CT-scan (time frame: Baseline). 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 1 Jun 2026.