Lung Transplant RejectionPhase 2NCT05550662
HP 129Xe MRI for Evaluation of CLAD in Lung Transplant Recipients
A Phase 2 study testing 129Xenon in people with Lung Transplant Rejection, run by The Hospital for Sick Children at 2 sites in Canada.
Trial summary
To evaluate the feasibility of hyperpolarized 129Xe MRI in lung transplant recipients and assess structural and functional pulmonary changes using hyperpolarized 129Xe MRI Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Transplant Rejection
- What is being tested?
- 129Xenon
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 2 sitesCanada
- Study dates
- 7 Feb 2024to 2 Aug 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients, deemed clinically stable by the lung transplant team at UHN Toronto Lung Transplant Program (TLTP), 18 years of age or older
- Double lung transplant recipient
- For the 5 CLAD-free participants - at least 1 year of follow-up post-LTx and no substantial and persistent FEV1 decline (as per the ISHLT CLAD definition).
- For the 10 participants with CLAD - prior diagnosis of CLAD made by the clinical team (member of the TLTP).
- PFT measurements within 1 month of scan visit.
- FEV1 > 1.0 L
Who cannot join
- Currently pregnant or lactating
- Psychiatric or addictive disorders that would preclude obtaining informed consent or adherence to protocol
- Inability to travel to obtain MRI scan
- Any contraindications to MRI including but not limited to severe claustrophobia, implanted devices, aneurysm clips, neurostimulators (patients will be prescreened prior to registration).
- Baseline oxygen saturation of less than 88%.
- Requiring supplemental oxygen at baseline
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Hospital for Sick Chilldren
Toronto, Ontario, M5G 1X8
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8
About this study
Official title: Hyperpolarized 129Xe Magnetic Resonance Imaging for Evaluation of Chronic Lung Allograft Dysfunction in Lung Transplant Recipients
To evaluate the feasibility of hyperpolarized 129Xe MRI in lung transplant recipients and assess structural and functional pulmonary changes using hyperpolarized 129Xe MRI
Read the detailed description
Lung transplantation is an effective treatment for end-stage lung disease. However, median survival post-LTx is 6 years. This is primarily due to chronic lung allograft dysfunction (CLAD).
Clinical management of LTx recipients is focused on identifying early risk factors for CLAD, by monitoring graft function with spirometry and transbronchial biopsies. However, both have significant limitations.
Hyperpolarized (HP) noble gas lung MRI (3He and 129Xe) allows mapping of both lung anatomy and function. 129Xe-MRI could provide a diagnostic tool that is able to detect CLAD more sensitively and earlier than the current gold standard measurements of spirometry and plethysmography, and thus allow a means to detect and prevent /slow down irreparable and irreversible damage to the lungs in the early stages of disease.
- Conditions
- Lung Transplant Rejection
- Being tested
- 129Xenon
- Keywords
- Lung MRI, 129Xenon, Lung transplant recipient, Chronic lung allograft dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
129XenonDrug
Also called Hyperpolarized Xenon Gas
There is no study medication evaluated. As part of the MRI, participants will inhale hyperpolarized 129Xe gas at a dose of up to 1/6th of total lung capacity (TLC) (lung volume), mixed with nitrogen to a total volume of 1.5 L. The polarized 129Xe will be inhaled in a single breath-hold. This is intended to fill the lungs gas, allowing for lung MRI.
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | Participants will inhale hyperpolarized 129Xe gas. Receives: Drug: 129Xenon |
What is being measured
The primary outcome is the main question the study is designed to answer.
129Xe-MRI
Ventilation defect percent (VDP)
Measured: 1 year
Secondary outcomes (1)
1H-MRI
Structural features
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start7 Feb 2024
- Primary completion2 Aug 2024
- Study completion2 Aug 2024
Why it stopped: Recruitment challenges
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Transplant RejectionStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- We will map lung ventilation (V), perfusion (Q), apparent diffusion coefficient (ADC) and gas exchange using 129Xe MRI in 15 LTx recipients. All MRI scans will be acquired in one visit
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- University Health Network, Toronto
- 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
- NCT05550662
- Sponsor's protocol ID
- 1000078240
- Status last verified
- Aug 2025
- First submitted
- 19 Sep 2022
- Last updated
- 4 Sep 2025
- 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 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperpolarized 129Xe Magnetic Resonance Imaging for Evaluation of Chronic Lung Allograft Dysfunction in Lung Transplant Recipients
- ClinicalTrials.gov ID
- NCT05550662
- Acronym / sponsor ID
- 1000078240
- Conditions
- Lung Transplant Rejection
- Keywords
- Lung MRI, 129Xenon, Lung transplant recipient, Chronic lung allograft dysfunction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment challenges
- Enrolment
- 6 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- University Health Network, Toronto
- Study start
- 7 Feb 2024 (actual)
- Primary completion
- 2 Aug 2024 (actual)
- Study completion
- 2 Aug 2024 (actual)
- First posted
- 22 Sep 2022 (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.
To evaluate the feasibility of hyperpolarized 129Xe MRI in lung transplant recipients and assess structural and functional pulmonary changes using hyperpolarized 129Xe MRI
Detailed description
Lung transplantation is an effective treatment for end-stage lung disease. However, median survival post-LTx is 6 years. This is primarily due to chronic lung allograft dysfunction (CLAD).
Clinical management of LTx recipients is focused on identifying early risk factors for CLAD, by monitoring graft function with spirometry and transbronchial biopsies. However, both have significant limitations.
Hyperpolarized (HP) noble gas lung MRI (3He and 129Xe) allows mapping of both lung anatomy and function. 129Xe-MRI could provide a diagnostic tool that is able to detect CLAD more sensitively and earlier than the current gold standard measurements of spirometry and plethysmography, and thus allow a means to detect and prevent /slow down irreparable and irreversible damage to the lungs in the early stages of disease.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- We will map lung ventilation (V), perfusion (Q), apparent diffusion coefficient (ADC) and gas exchange using 129Xe MRI in 15 LTx recipients. All MRI scans will be acquired in one visit
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Drug: 129XenonParticipants will inhale hyperpolarized 129Xe gas. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients, deemed clinically stable by the lung transplant team at UHN Toronto Lung Transplant Program (TLTP), 18 years of age or older
- Double lung transplant recipient
- For the 5 CLAD-free participants - at least 1 year of follow-up post-LTx and no substantial and persistent FEV1 decline (as per the ISHLT CLAD definition).
- For the 10 participants with CLAD - prior diagnosis of CLAD made by the clinical team (member of the TLTP).
- PFT measurements within 1 month of scan visit.
Key exclusion criteria (6 listed)
- Currently pregnant or lactating
- Psychiatric or addictive disorders that would preclude obtaining informed consent or adherence to protocol
- Inability to travel to obtain MRI scan
- Any contraindications to MRI including but not limited to severe claustrophobia, implanted devices, aneurysm clips, neurostimulators (patients will be prescreened prior to registration).
- Baseline oxygen saturation of less than 88%.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 129XenonAlso: Hyperpolarized Xenon GasThere is no study medication evaluated. As part of the MRI, participants will inhale hyperpolarized 129Xe gas at a dose of up to 1/6th of total lung capacity (TLC) (lung volume), mixed with nitrogen to a total volume of 1.5 L. The polarized 129Xe will be inhaled in a single breath-hold. This is intended to fill the lungs gas, allowing for lung MRI. | Drug | Single arm |
Primary outcome
129Xe-MRI
Time frame: 1 year
Ventilation defect percent (VDP)
1 secondary outcome
1H-MRI
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Recruitment challenges). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Lung Transplant Rejection
RecruitingPhase 1
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Lung Transplantation
RecruitingPhase 3
A Study to Test How Effective Belumosudil Tablets Are for Treating Adult Participants With Chronic Lung Allograft Dysfunction
Lung Transplant Rejection
RecruitingPhase 1
A Phase 1 Clinical Trial of Siltuximab for the Treatment of Antibody-Mediated Rejection After Lung Transplantation
Antibody Mediated Rejection of Lung Transplant
RecruitingPhase 2
Belumosudil to Block Chronic Lung Allograft Dysfunction (CLAD) in High Risk Lung Transplant Recipients
Lung Transplant
RecruitingObservational study
Prospective Multicenter Research on Donor and Recipient Management Strategies to Improve Lung Transplant Outcomes
Lung Transplant; Complications, Lung Transplant; Infection or Inflammation
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. This study is not recruiting at the moment.
Giles Santyr, PhD principal investigator
The Hospital for Sick Children
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 129Xenon in people with Lung Transplant Rejection, run by The Hospital for Sick Children at 2 sites 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 6 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: stopped early, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Recruitment challenges). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
129Xe-MRI (time frame: 1 year). 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 4 Sep 2025.