Bronchiolitis Obliterans Clinical Trial
Official title:
Imaging and Understanding Bronchiolitis Obliterans Syndrome (BOS) in Lung Transplantation With Hyperpolarized 129Xenon MR Lung Imaging
The research is being conducted to develop new imaging methods that are sufficiently sensitive to allow for early diagnosis of BOS, a chronic allograft rejection affecting 50-60% of lung transplanted recipients who survive 5 years after transplant. Although lung transplantation has evolved into an effective therapeutic option for a large number of pediatric patients with end-stage pulmonary disease, long-term survival after lung transplantation is far worse than after the transplantation of other solid organs. This research may improve patient outcomes through earlier diagnosis of changes leading to BOS by obtaining image guided research biopsies of transplanted lung. Biopsies may be used for future research of ex vivo biomarkers of BOS and in the development of treatments through future clinical trials.
Status | Recruiting |
Enrollment | 45 |
Est. completion date | October 2027 |
Est. primary completion date | October 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital Medical Center, Cincinnati |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Capture 129Xe and proton MRI Images for clinician assessment | Capture HP 129Xe and 1H MR images for clinician review for regional ventilation defects in post-transplant BOS patients during routine clinical visits | 6 months post transplant | |
Secondary | Capture 129Xe and proton MRI Images for clinician assessment | Capture HP 129Xe and 1H MR images for clinician review for regional ventilation defects in post-transplant BOS patients during routine clinical visits | 12 months post transplant |
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