- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04391335
Novel Pulmonary Function Measures for Diagnosis of Bronchiolitis Obliterans Syndrome Following Hematopoietic Stem-Cell Transplantation in Children
April 15, 2024 updated by: Giles Santyr, The Hospital for Sick Children
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.
Study Overview
Status
Recruiting
Conditions
Study Type
Observational
Enrollment (Estimated)
15
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Giles Santyr
- Phone Number: 301394 4168137654
- Email: giles.santyr@sickkids.ca
Study Contact Backup
- Name: Sharon Braganza
- Phone Number: 307937 4168137654
- Email: sharon.braganza@sickkids.ca
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5G 1X8
- Recruiting
- The Hospital for Sick Children
-
Principal Investigator:
- Giles Santyr, PhD FCCPM
-
Contact:
- Giles Santyr, PhD FCCPM
- Email: giles.santyr@sickkids.ca
-
Contact:
- Sharon Braganza
- Phone Number: 307937 416 813 7654
- Email: sharon.braganza@sickkids.ca
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 18 years (Child, Adult)
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.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of MRI
Time Frame: 24 months
|
Perform xenon MRI, in participants with and without a diagnosis of BOS as defined by NIH criteria.
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation
Time Frame: 24 months
|
Correlate MRI with conventional breathing tests
|
24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Giles Santyr, PhD, The Hospital for Sick Children
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 20, 2020
Primary Completion (Estimated)
December 31, 2024
Study Completion (Estimated)
December 31, 2024
Study Registration Dates
First Submitted
May 12, 2020
First Submitted That Met QC Criteria
May 12, 2020
First Posted (Actual)
May 18, 2020
Study Record Updates
Last Update Posted (Actual)
April 16, 2024
Last Update Submitted That Met QC Criteria
April 15, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Immune System Diseases
- Lung Diseases
- Disease
- Bronchial Diseases
- Lung Diseases, Obstructive
- Bronchitis
- Organizing Pneumonia
- Graft vs Host Disease
- Syndrome
- Bronchiolitis
- Bronchiolitis Obliterans
- Bronchiolitis Obliterans Syndrome
Other Study ID Numbers
- 1000063459
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Bronchiolitis Obliterans Syndrome
-
University Hospital, Basel, SwitzerlandRecruitingBronchiolitis Obliterans Syndrome (BOS) | Bronchiolitis Obliterans (BO)Switzerland, Saudi Arabia
-
Renovion, Inc.RecruitingPre-Bronchiolitis Obliterans SyndromeUnited States
-
Washington University School of MedicineThe Foundation for Barnes-Jewish Hospital; Mallinckrodt; Centers for Medicare...Active, not recruitingBronchiolitis Obliterans Syndrome (BOS)United States
-
Zambon SpATerminatedStem Cell Transplant Complications | GVHD, Chronic | Bronchiolitis Obliterans Syndrome (BOS)Spain, France, Germany
-
KU LeuvenUniversity Hospital, Gasthuisberg; Fund for Scientific Research, Flanders,...CompletedGraft Rejection | Respiratory Infection | Bronchiolitis Obliterans Syndrome | Lymphocytic BronchiolitisBelgium
-
Hopital FochCompletedBronchiolitis Obliterans SyndromeFrance
-
Ann & Robert H Lurie Children's Hospital of ChicagoUnknownBronchiolitis Obliterans SyndromeUnited States
-
University of ChicagoCompletedBronchiolitis Obliterans SyndromeUnited States
-
Children's Hospital Medical Center, CincinnatiRecruitingBronchiolitis Obliterans (BO) | Hematopoietic Stem Cell Transplant (HSCT)United States
-
Hannover Medical SchoolUnknownLung Transplantation | Bronchiolitis Obliterans SyndromeGermany