Using advanced imaging to diagnose lung issues in children after stem cell transplants
Novel Pulmonary Function Measures for Diagnosis of Bronchiolitis Obliterans Syndrome Following Hematopoietic Stem-Cell Transplantation in Children
This study is testing new imaging techniques to see if they can help doctors better diagnose lung problems in children who have had stem cell transplants.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 15 (estimated) |
| Ages | 6 Years to 18 Years |
| Sex | All |
| Sponsor | The Hospital for Sick Children Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT04391335 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of 129Xe-MRI and Lung Clearance Index (LCI) as diagnostic tools for Bronchiolitis Obliterans Syndrome (BOS) in pediatric patients who have undergone Hematopoietic Stem Cell Transplantation (HSCT). Participants aged 6 to 17.9 years will undergo vital sign assessments, breathing tests, and MRI scans involving breath holds with xenon gas. The goal is to evaluate the effectiveness of these imaging techniques in identifying lung complications following HSCT. The study aims to enhance diagnostic accuracy for BOS in this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates are children aged 6 to 17.9 years who have received HSCT at least six months prior and have a sufficient lung function as indicated by FEV1%pred values.
Not a fit: Patients who have had recent respiratory infections, require supplemental oxygen, or cannot perform necessary breathing tests may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic methods for lung complications in children post-transplant, potentially enhancing patient outcomes.
How similar studies have performed: While the use of advanced imaging techniques in lung diagnostics is promising, this specific approach using 129Xe-MRI for BOS in pediatric HSCT patients is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Toronto, Ontario
- The Hospital for Sick Children — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Giles Santyr, PhD — The Hospital for Sick Children
- Study coordinator: Giles Santyr
- Email: giles.santyr@sickkids.ca
- Phone: 4168137654
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.