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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

France1 site
  • CHU Bordeaux

    Bordeaux

Other trials in France

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.

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 groups in NCT04080232
Study groupRoleWhat they receive
Lung MRIExperimentallung 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.

  1. 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)
  1. Bhalla Score precision in morphological MRI

    Measure of Bhalla Score precision in morphological MRI for the diagnosis of post-transplant BOS

    Measured: Baseline

  2. Bhalla Score in CT scan

    Bhalla Score in CT scan

    Measured: Baseline

  3. oxygen transfer capacity

    Measure of oxygen transfer capacity (percentage of intra-pulmonary signal variation before and after inhalation of oxygen);

    Measured: Baseline

  4. Force Expiratory Volume

    Force Expiratory Volume (FEV, l)

    Measured: Baseline

  5. FEV1/VC

    FEV1/VC (Tiffeneau),

    Measured: Baseline

  6. Residual volume

    Residual volume (l)

    Measured: Baseline

  7. total lung capacity

    Total lung capacity (l)

    Measured: Baseline

  8. 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

  9. intra-observer repeatability of the Bhalla score in CT scan

    Intraclass coefficient and Bland-Altman's test

    Measured: Baseline

  10. intra-observer repeatability of the Bhalla score in MRI

    Intraclass coefficient and Bland-Altman's test

    Measured: Baseline

  11. intra-observer repeatability of the measure of oxygen transfer capacity

    Intraclass coefficient and Bland-Altman's test

    Measured: Baseline

  12. inter-observer reproducibility of the Bhalla score in CT scan

    Intraclass coefficient and Bland-Altman's test

    Measured: Baseline

  13. inter-observer reproducibility of the Bhalla score in MRI

    Intraclass coefficient and Bland-Altman's test

    Measured: Baseline

  14. 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.

  1. First posted6 Sep 2019
  2. Study start6 Feb 2020
  3. Primary completion11 May 2023
  4. Study completion11 May 2023

Resources

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)
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

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.

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