Novel Pulmonary Function Measures for Diagnosis of Bronchiolitis Obliterans Syndrome Following Hematopoietic Stem-Cell Transplantation in Children

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-18
SponsorThe Hospital for Sick Children

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 volunteers

Qualifiers

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

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

15 Participants
are grouped into 2 trial groups
Group A: Group 1
Group B: Group 2

Trial outcomes

Primary outcomes

1

Assessment of MRI

Perform xenon MRI, in participants with and without a diagnosis of BOS as defined by NIH criteria.

Time frame
24 months

Secondary outcomes

1

Correlation

Correlate MRI with conventional breathing tests

Time frame
24 months

Other outcomes

Sponsors and contacts

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