Actively Recruiting

Age: 6Years - 18Years
All Genders
ID04391335

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

Led by The Hospital for Sick Children · Updated on 2026-02-27

15

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating new ways to diagnose Bronchiolitis Obliterans Syndrome (BOS) in children who have undergone Hematopoietic Stem Cell Transplantation (HSCT). This study focuses on using a special type of MRI with xenon gas (129Xe-MRI) and lung clearance index (LCI) tests to better detect BOS. Participants include children aged 6 to 18 years who have received HSCT and are eligible based on lung function and other criteria. Participants are divided into two groups: those who meet the screening criteria for BOS according to NIH standards and those who may have abnormal lung tests but do not fully meet BOS criteria. During the study, children will undergo vital sign monitoring, breathing tests, and a specialized MRI that requires breath holds while inhaling xenon gas, guided by research staff. The study will assess MRI results and lung function over 24 months. Throughout the study, participants will be asked to complete breathing tests and MRIs, with vital signs collected during visits. The MRI involves breath holds lasting up to 16 seconds. Researchers will monitor lung function and imaging results to understand how well these tools diagnose BOS. The study aims to better correlate imaging findings with lung function in children after HSCT, with follow-up lasting up to two years.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 6Years - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male and female participants aged 6 to 17.9 years old
  • Received hematopoietic stem cell transplantation at least 6 months prior to enrollment
  • FEV1% predicted value greater than 40%
  • Understands study procedures and consents or assents to participate
  • Able to perform breath hold for 16 seconds
  • Meets MRI screening criteria
Not Eligible

You will not qualify if you...

  • Recent cold or respiratory infection within the last four weeks
  • Requires supplemental oxygen or has daytime oxygen saturation less than or equal to 95%
  • Unable to perform spirometry or plethysmography maneuvers
  • Pregnant or lactating

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - 24 months

Participants undergo MRI assessments to evaluate for bronchiolitis obliterans syndrome following hematopoietic stem-cell transplantation.

Regular assessments during this period

Long-term Monitoring

Duration - 24 months

Participants are observed over time to monitor pulmonary function and correlate MRI findings.

Ongoing monitoring visits over 24 months

Trial Site Locations

Total: 1 location

1

The Hospital for Sick Children

Toronto, Ontario, Canada, M5G 1X8

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Research Team

G

Giles Santyr

S

Sharon Braganza

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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