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

Bronchiolitis Obliterans Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04391335
• Other study ID #: 1000063459
• Status: Recruiting
• Start date: October 20, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: The Hospital for Sick Children
• Contact: Giles Santyr
• Phone: 4168137654
• Email: giles.santyr[@]sickkids.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bronchiolitis
• Bronchiolitis Obliterans
• Bronchiolitis Obliterans Syndrome
• Syndrome

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of MRI	Perform xenon MRI, in participants with and without a diagnosis of BOS as defined by NIH criteria.	24 months
Secondary	Correlation	Correlate MRI with conventional breathing tests	24 months