Recruiting

Observational Study

Sponsor:

The Hospital for Sick Children

Code:

NCT04391335

Conditions

Bronchiolitis Obliterans Syndrome

Eligibility Criteria

Sex: All

Age: 6 - 18

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Bronchiolitis Obliterans Syndrome

Study ID

NCT04391335

Start date

Oct 20, 2020

Status verified date

Feb, 2026

Completion date

Jun 30, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 18

Healthy Volunteers: Not accepted

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

Enrollment

15 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Primary outcome measure

  • Assessment of MRI [ Time Frame: 24 months ]

Central Contacts and Locations

Central contacts

Giles Santyr

4168137654giles.santyr@sickkids.ca

Sharon Braganza

4168137654sharon.braganza@sickkids.ca

Locations

The Hospital for Sick Children

Recruiting

Toronto, Ontario, Canada, M5G 1X8

Contacts

Giles Santyr, PhD FCCPM

giles.santyr@sickkids.ca

Sharon Braganza

416 813 7654sharon.braganza@sickkids.ca

Principal Investigator:

Giles Santyr, PhD FCCPM

More Information

Sponsor

The Hospital for Sick Children

Last update posted

Feb 27, 2026

Last verified

Feb, 2026

Keywords

  • Stem cell transplantation
  • Xenon MRI
  • Lung

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Hospital for Sick Children on 2026-02-27.