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

NCT04391335 | Recruiting

• 1 other identifier: 1000063459
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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

Keywords

Stem cell transplantation; Xenon MRI; Lung

Outcome Measures

Primary Outcomes (1)

• Assessment of MRI

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

  24 months

Secondary Outcomes (1)

• Correlation

  24 months

Study Arms (2)

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

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

RECRUITING

MeSH Terms

Conditions

Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

• Giles Santyr, PhD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giles Santyr

CONTACT

4168137654; giles.santyr@sickkids.ca

Sharon Braganza

CONTACT

4168137654; sharon.braganza@sickkids.ca

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist

Study Record Dates

• First Submitted: May 12, 2020
• First Posted: May 18, 2020
• Study Start: October 20, 2020
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)