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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04391335
Recruitment Status : Not yet recruiting
First Posted : May 18, 2020
Last Update Posted : May 18, 2020
Sponsor:
Information provided by (Responsible Party):
Giles Santyr, The Hospital for Sick Children

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.

Condition or disease
Bronchiolitis Obliterans Syndrome

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Study Type : Observational
Estimated Enrollment : 15 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Novel Pulmonary Function Measures for Diagnosis of Bronchiolitis Obliterans Syndrome Following Hematopoietic Stem-Cell Transplantation in Children
Estimated Study Start Date : June 2020
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


Group/Cohort
Group 1
Participants who meet the screening criteria for the development of bronchiolitis obliterans syndrome (BOS) according to the NIH criteria
Group 2
Participants who may or may not have abnormal spirometry; however they do not fulfill the NIH criteria for the development of BOS



Primary Outcome Measures :
  1. Assessment of MRI [ Time Frame: 24 months ]
    Perform xenon MRI, in participants with and without a diagnosis of BOS as defined by NIH criteria.


Secondary Outcome Measures :
  1. Correlation [ Time Frame: 24 months ]
    Correlate MRI with conventional breathing tests



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study 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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04391335


Contacts
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Contact: Giles Santyr 4168137654 ext 301394 giles.santyr@sickkids.ca
Contact: Elaine Stirrat 4168137654 ext 307937 elaine.stirrat@sickkids.ca

Sponsors and Collaborators
The Hospital for Sick Children
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Responsible Party: Giles Santyr, Senior Scientist, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT04391335    
Other Study ID Numbers: 1000063459
First Posted: May 18, 2020    Key Record Dates
Last Update Posted: May 18, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Giles Santyr, The Hospital for Sick Children:
Stem cell transplantation
Xenon MRI
Lung
Additional relevant MeSH terms:
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Bronchiolitis
Bronchiolitis Obliterans
Syndrome
Disease
Pathologic Processes
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections