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

Sponsor

The Hospital for Sick Children (Other)

Overall Status

Recruiting

CT.gov ID

NCT04391335

Collaborator

(none)

Enrollment

Location

19.4

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bronchiolitis Obliterans Syndrome

Study Design

Study Type:

Observational

Anticipated Enrollment :

15 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Oct 20, 2020

Anticipated Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Jun 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

Assessment of MRI [24 months]
Perform xenon MRI, in participants with and without a diagnosis of BOS as defined by NIH criteria.

Secondary Outcome Measures

Correlation [24 months]
Correlate MRI with conventional breathing tests

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 18 Years

Sexes Eligible for Study:

All

Accepts 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.