ClinicalTrials.Veeva

Menu

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

T

The Hospital for Sick Children

Status

Enrolling

Conditions

Bronchiolitis Obliterans Syndrome

Study type

Observational

Funder types

Other

Identifiers

NCT04391335
1000063459

Details and patient eligibility

About

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.

Enrollment

15 estimated patients

Sex

All

Ages

6 to 18 years old

Volunteers

No 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.

Trial design

15 participants in 2 patient groups

Group 1
Description:
Participants who meet the screening criteria for the development of bronchiolitis obliterans syndrome (BOS) according to the NIH criteria
Group 2
Description:
Participants who may or may not have abnormal spirometry; however they do not fulfill the NIH criteria for the development of BOS

Trial contacts and locations

1

Loading...

Central trial contact

Sharon Braganza; Giles Santyr

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems