NCT04391335 Novel Pulmonary Function Measures for Diagnosis of Bronchiolitis Obliterans Syndrome Following Hematopoietic Stem-Cell Transplantation in Children
| NCT ID | NCT04391335 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Hospital for Sick Children |
| Condition | Bronchiolitis Obliterans Syndrome |
| Study Type | OBSERVATIONAL |
| Enrollment | 15 participants |
| Start Date | 2020-10-20 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 15 participants in total. It began in 2020-10-20 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Giles Santyr, PhD
PRINCIPAL INVESTIGATOR
The Hospital for Sick Children
Frequently Asked Questions
Who can join the NCT04391335 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 18 Years, studying Bronchiolitis Obliterans Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04391335 currently recruiting?
Yes, NCT04391335 is actively recruiting participants. Contact the research team at giles.santyr@sickkids.ca for enrollment information.
Where is the NCT04391335 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT04391335 clinical trial?
NCT04391335 is sponsored by The Hospital for Sick Children. The principal investigator is Giles Santyr, PhD at The Hospital for Sick Children. The trial plans to enroll 15 participants.