Novel Pulmonary Function Measures for Diagnosis of Bronchiolitis Obliterans Syndrome Following Hematopoietic Stem-Cell Transplantation in Children

Recruiting

• Conditions: Bronchiolitis Obliterans Syndrome

• Registration Number: NCT04391335
• Lead Sponsor: The Hospital for Sick Children

Brief Summary

In this study, we will study 129Xe-MRI and LCI as tools for diagnosis of BOS in pediatric patients who have received Hematopoietic Stem Cell Transplantation (HSCT) and have been identified as eligible for this study. Participants will be required to have vital signs collected, complete breathing tests and complete an MRI. The MRI will require participants to perform breath holds in the MRI scanner with xenon gas while being coached by a research assistant.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-12
• Study First Submitted QC: 2020-05-12
• Study First Posted: 2020-05-18
• Study Start: 2020-10-20
• Status Verified: 2024-04
• Last Update Submitted: 2025-03-19
• Last Update Posted: 2025-03-24
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Male and female participants aged 6 -17.9 years old.
• Received HSCT treatment at least 6 months prior to enrollment in study.
• Participants should have an FEV1%pred value greater than 40%.
• Participant understands the study procedures and is willing to participate in the study as indicated by signature on the informed consent or assent.
• Participant must be able to perform a breath hold for 16s.
• Participant meets MRI screening criteria

Exclusion Criteria

• Participant has had a cold or respiratory infection in the last four weeks.
• Participant requires supplemental oxygen or has a daytime room air oxygen saturation ≤ 95%.
• Participant is unable to perform spirometry or plethysmography maneuvers.
• Participant is pregnant or lactating.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of MRI	24 months	Perform xenon MRI, in participants with and without a diagnosis of BOS as defined by NIH criteria.

Secondary Outcome Measures

Name	Time	Method
Correlation	24 months	Correlate MRI with conventional breathing tests

Trial Locations

Locations (1)

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada