Using hyperpolarized 129Xe MRI to evaluate lung transplant rejection
Hyperpolarized 129Xe Magnetic Resonance Imaging for Evaluation of Chronic Lung Allograft Dysfunction in Lung Transplant Recipients
PHASE2 · The Hospital for Sick Children · NCT05550662
This study is testing a new type of MRI using hyperpolarized 129Xe to see if it can help doctors spot lung transplant rejection earlier and more accurately in patients.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | The Hospital for Sick Children (other) |
| Locations | 2 sites (Toronto, Ontario and 1 other locations) |
| Trial ID | NCT05550662 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the feasibility of hyperpolarized 129Xe MRI in lung transplant recipients to evaluate structural and functional changes in the lungs. It focuses on chronic lung allograft dysfunction (CLAD), a significant cause of morbidity and mortality in lung transplant patients. By utilizing 129Xe MRI, the study seeks to provide a more sensitive and earlier diagnostic tool compared to traditional methods like spirometry and biopsies, potentially allowing for timely interventions to prevent irreversible lung damage.
Who should consider this trial
Good fit: Ideal candidates include stable double lung transplant recipients aged 18 and older, with or without a diagnosis of CLAD.
Not a fit: Patients who are currently pregnant, have psychiatric disorders, or cannot undergo MRI due to contraindications will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to earlier detection and management of lung transplant rejection, improving patient outcomes.
How similar studies have performed: While hyperpolarized gas MRI is a novel approach in this context, similar imaging techniques have shown promise in other pulmonary conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Toronto, Ontario and 1 other locations
- Hospital for Sick Chilldren — Toronto, Ontario, Canada (RECRUITING)
- The Hospital for Sick Children — Toronto, Ontario, Canada (RECRUITING)
Study contacts
- Principal investigator: Giles Santyr, PhD — The Hospital for Sick Children
- Study coordinator: Giles Santyr, PhD
- Email: giles.santyr@sickkids.ca
- Phone: 416-813-7654
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Lung Transplant Rejection, Lung MRI, 129Xenon, Lung transplant recipient, Chronic lung allograft dysfunction