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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-20

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Bronchiolitis Obliterans Syndrome

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Participants who meet the screening criteria for the development of bronchiolitis obliterans syndrome (BOS) according to the NIH criteria

No interventions assigned to this group

Group 2

Participants who may or may not have abnormal spirometry; however they do not fulfill the NIH criteria for the development of BOS

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No