Status:
COMPLETED
Study of Pulmonary MRI for the Diagnosis of Bronchiolitis Obliterans Syndrome After Allogeneic Stem Cell Transplantation
Lead Sponsor:
University Hospital, Bordeaux
Collaborating Sponsors:
SFGM-TC
Conditions:
Bronchiolitis Obliterans
Eligibility:
All Genders
18+ years
Phase:
NA
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 dia...
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 (...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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 ;
Key Trial Info
Start Date :
February 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 11 2023
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT04080232
Start Date
February 6 2020
End Date
May 11 2023
Last Update
November 14 2024
Active Locations (1)
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1
CHU Bordeaux
Bordeaux, France