Study of Pulmonary MRI for the Diagnosis of Bronchiolitis Obliterans Syndrome After Allogeneic Stem Cell Transplantation

NCT04080232 | Completed

• 1 other identifier: CHUBX 2017/05
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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). 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

Conditions

Bronchiolitis Obliterans

Keywords

lung MRI performance; UTE; quantification; oxygen transfer; Bronchiolitis Obliterans syndrome; allogeneic stem cell transplantation

Outcome Measures

Primary Outcomes (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.

  Baseline

Secondary Outcomes (14)

• Bhalla Score precision in morphological MRI

  Baseline

• Bhalla Score in CT scan

  Baseline

• oxygen transfer capacity

  Baseline

• Force Expiratory Volume

  Baseline

• FEV1/VC

  Baseline

Study Arms (1)

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

Device: lung MRI

Interventions

lung MRI DEVICE

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.

Lung MRI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 ;

Sponsors & Collaborators

• University Hospital, Bordeaux: lead
• SFGM-TC: collaborator

Study Sites (1)

CHU Bordeaux

Bordeaux, France

Location

MeSH Terms

Conditions

Bronchiolitis Obliterans; Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Organizing Pneumonia; Graft vs Host Disease; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2019
• First Posted: September 6, 2019
• Study Start: February 6, 2020
• Primary Completion: May 11, 2023
• Study Completion: May 11, 2023
• Last Updated: November 14, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)