Bronchiolitis Obliterans SyndromeNCT04391335
Novel Pulmonary Function Measures for Diagnosis of Bronchiolitis Obliterans Syndrome Following Hematopoietic Stem-Cell Transplantation in Children
An observational study of Bronchiolitis Obliterans Syndrome, run by The Hospital for Sick Children at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Bronchiolitis Obliterans Syndrome
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- 20 Oct 2020to 30 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8
Giles Santyr, PhD FCCPM, giles.santyr@sickkids.ca
Sharon Braganza, 416 813 7654 ext. 307937, sharon.braganza@sickkids.ca
About this study
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.
- Conditions
- Bronchiolitis Obliterans Syndrome
- Keywords
- Stem cell transplantation, Xenon MRI, Lung
- Medical subject headings
- Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Assessment of MRI
Perform xenon MRI, in participants with and without a diagnosis of BOS as defined by NIH criteria.
Measured: 24 months
Secondary outcomes (1)
Correlation
Correlate MRI with conventional breathing tests
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2020
- Study start20 Oct 2020
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchiolitis Obliterans SyndromeStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giles Santyr, The Hospital for Sick Children
- Investigators
- Giles Santyr, PhD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04391335
- Sponsor's protocol ID
- 1000063459
- Status last verified
- Feb 2026
- First submitted
- 12 May 2020
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Pulmonary Function Measures for Diagnosis of Bronchiolitis Obliterans Syndrome Following Hematopoietic Stem-Cell Transplantation in Children
- ClinicalTrials.gov ID
- NCT04391335
- Acronym / sponsor ID
- 1000063459
- Conditions
- Bronchiolitis Obliterans Syndrome
- Keywords
- Stem cell transplantation, Xenon MRI, Lung
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- 20 Oct 2020 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 18 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment of MRI
Time frame: 24 months
Perform xenon MRI, in participants with and without a diagnosis of BOS as defined by NIH criteria.
1 secondary outcome
Correlation
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Giles Santyr, PhD principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchiolitis Obliterans Syndrome, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giles Santyr (4168137654 ext. 301394, giles.santyr@sickkids.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of MRI (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.