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NCT Number: NCT04391335

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

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.

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Key information

Conditions

Bronchiolitis Obliterans Syndrome Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchitis Graft vs Host Disease Immune System Diseases Lung Diseases Lung Diseases, Obstructive Organizing Pneumonia Respiratory Tract Diseases

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location status: Recruiting

Location contact

Giles Santyr, PhD FCCPM

CONTACT

[email protected]

Giles Santyr, PhD FCCPM

PRINCIPAL_INVESTIGATOR

Sharon Braganza

CONTACT

[email protected]

416 813 7654 ext. 307937

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Assessment of MRI

    Time frame: 24 months

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

Secondary outcomes

  1. Correlation

    Time frame: 24 months

    Correlate MRI with conventional breathing tests

Study contacts

Contact information is provided by the study sponsor or research team.

Giles Santyr

CONTACT

[email protected]

4168137654 ext. 301394

Sharon Braganza

CONTACT

[email protected]

4168137654 ext. 307937

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
May 18, 2020
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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