Novel Pulmonary Function Measures for Diagnosis of Bronchiolitis Obliterans Syndrome Following Hematopoietic Stem-Cell Transplantation in Children
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Bronchiolitis Obliterans Syndrome. Basic parameters: 6 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Assessment of MRI [Time frame: 24 months]
Secondary outcome measures (1)
- Correlation [Time frame: 24 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
Canada · 1 center
- The Hospital for Sick Children — Toronto
Identifiers
NCT: NCT04391335 · 1000063459