RecruitingNCT04391335
Novel Pulmonary Function Measures for Diagnosis of Bronchiolitis Obliterans Syndrome Following Hematopoietic Stem-Cell Transplantation in Children
Sponsor
The Hospital for Sick Children
Enrollment
15 participants
Start Date
Oct 20, 2020
Study Type
OBSERVATIONAL
Conditions
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.
Eligibility
Min Age: 6 YearsMax Age: 18 Years
Inclusion Criteria6
- 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 Criteria4
- 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.
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Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04391335
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