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RecruitingNCT04391335Updated Feb 27, 2026

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

An observational study in Bronchiolitis Obliterans Syndrome, sponsored by The Hospital for Sick Children. Recruiting at 1 site in Canada. Open to participants aged 6 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-02-27.

Sponsored by The Hospital for Sick Children · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2026, 3 months ago, but the record still lists the study as recruiting.
  • Started Oct 2020; still recruiting 5 years 11 months later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
15
Ages
6 Years to 18 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Bronchiolitis Obliterans Syndrome

Keywords

  • Stem cell transplantation
  • Xenon MRI
  • Lung
03

In context

Bronchiolitis Obliterans Syndrome

376 studies on the registry are indexed under Bronchiolitis Obliterans Syndrome; 104 are open to participants now.

This study's planned enrollment of 15 is below the median of 108 across 69 observational studies indexed under Bronchiolitis Obliterans Syndrome.

Browse Bronchiolitis Obliterans Syndrome studies →

Lead sponsor

The Hospital for Sick Children is the lead sponsor of 568 studies on the registry; 81 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Two groups of participants will be recruited. Group 1 will be participants who meet the screening criteria for the development of BOS according to the NIH criteria. Group 2 will be participants who may or may not have abnormal spirometry; however they do not fulfill the NIH criteria for the development of BOS.

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

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.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
15 participants (estimated)
Patient registry
No

Groups and cohorts

  • Group 1

    Participants who meet the screening criteria for the development of bronchiolitis obliterans syndrome (BOS) according to the NIH criteria

  • Group 2

    Participants who may or may not have abnormal spirometry; however they do not fulfill the NIH criteria for the development of BOS

06

What researchers measure

Primary outcomes

  1. Assessment of MRI

    Perform xenon MRI, in participants with and without a diagnosis of BOS as defined by NIH criteria.

    Time frame: 24 months

Secondary outcomes

  1. Correlation

    Correlate MRI with conventional breathing tests

    Time frame: 24 months

07

Study locations

1 of 1 sites recruiting
  • The Hospital for Sick Children
    Toronto, Ontario M5G 1X8, Canada
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04391335
Lead sponsor
The Hospital for Sick Children
Responsible party
Giles Santyr (Senior Scientist, The Hospital for Sick Children) — Principal investigator
First posted
May 18, 2020
Start date
Oct 20, 2020
Primary completion
Jun 30, 2026 (estimated)
Completion
Jun 30, 2026 (estimated)
Last update
Feb 27, 2026

Study contacts

Giles Santyr
Contact
giles.santyr@sickkids.ca
4168137654 ext. 301394
Sharon Braganza
Contact
sharon.braganza@sickkids.ca
4168137654 ext. 307937
Giles Santyr, PhD
principal investigator · The Hospital for Sick Children

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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