About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Two groups of participants will be recruited. Group 1 will be participants who meet the screening criteria for the development of BOS according to the NIH criteria. Group 2 will be participants who may or may not have abnormal spirometry; however they do not fulfill the NIH criteria for the development of BOS.
Trial design
Case-control
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Assessment of MRI
Perform xenon MRI, in participants with and without a diagnosis of BOS as defined by NIH criteria.
Secondary outcomes
Correlation
Correlate MRI with conventional breathing tests
Sponsors and contacts
Click on the lead sponsor to view all of their trials.