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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04391335

Enrollment

Registered

2020-05-18

Start date

2020-10-20

Completion date

2026-06-30

Last updated

2026-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchiolitis Obliterans Syndrome

Keywords

Stem cell transplantation, Xenon MRI, Lung

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

6 Years to 18 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Assessment of MRI	24 months	Perform xenon MRI, in participants with and without a diagnosis of BOS as defined by NIH criteria.

Secondary

Measure	Time frame	Description
Correlation	24 months	Correlate MRI with conventional breathing tests

Countries

Canada

Contacts

CONTACTGiles Santyr

giles.santyr@sickkids.ca4168137654

CONTACTSharon Braganza

sharon.braganza@sickkids.ca4168137654

PRINCIPAL_INVESTIGATORGiles Santyr, PhD

The Hospital for Sick Children

Outcome results