New imaging methods for early diagnosis of lung transplant rejection
Imaging and Understanding Bronchiolitis Obliterans Syndrome (BOS) in Lung Transplantation With Hyperpolarized 129Xenon MR Lung Imaging
This study is testing new imaging techniques to see if they can help find early signs of lung transplant rejection in patients.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 6 Years and up |
| Sex | All |
| Sponsor | Children's Hospital Medical Center, Cincinnati Academic / other |
| Locations | 1 site (Cincinnati, Ohio) |
| Trial ID | NCT03603899 on ClinicalTrials.gov |
What this trial studies
This research focuses on developing advanced imaging techniques to enable early detection of Bronchiolitis Obliterans Syndrome (BOS), a common chronic rejection condition in lung transplant recipients. The study will involve a longitudinal observational approach, recruiting approximately five subjects annually over five years. Participants will undergo 129Xe MRI and image-guided bronchial biopsies to identify early signs of BOS and to enhance understanding of the disease's progression. The biopsies collected will also support future research into biomarkers and potential treatments for BOS.
Who should consider this trial
Good fit: Ideal candidates include individuals who have undergone lung transplantation within the last 10 years or are being evaluated for potential lung transplantation.
Not a fit: Patients with bleeding disorders, claustrophobia, or those who cannot tolerate MRI procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier diagnosis and improved treatment options for lung transplant recipients at risk of BOS.
How similar studies have performed: While the approach of using advanced imaging for early diagnosis is promising, it is relatively novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Lung Transplantation within the last 10 years or being assessed for possible lung transplantation. * Participant must be able to hold their breath for up to 16 seconds. Exclusion Criteria: * Standard MRI exclusion criteria * Bleeding disorders * Participant is claustrophobic or otherwise unable to tolerate the imaging * Pregnancy or positive pregnancy test * Symptoms of respiratory infection within the past two weeks. * Baseline oximetry at MRI visit of less than 95% on room air or less than 95% on a previously prescribed dosage of oxygen delivered by nasal cannula.
Where this trial is running
Cincinnati, Ohio
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Jason Woods, PhD — Children's Hospital Medical Center, Cincinnati
- Study coordinator: Carrie Stevens, BS
- Email: carrie.stevens@cchmc.org
- Phone: (513) 636-9973
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.