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Hp129 Xenon Imaging and BOS in Lung Transplantation

Bronchiolitis Obliterans Clinical Trial

Official title:
Imaging and Understanding Bronchiolitis Obliterans Syndrome (BOS) in Lung Transplantation With Hyperpolarized 129Xenon MR Lung Imaging

Clinical Trial Summary

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.

Clinical Trial Description

This protocol aims to - Develop new imaging methods that are sufficiently sensitive to allow early diagnosis of BOS. - Improve patient treatment outcomes through earlier diagnosis of changes leading to BOS by obtaining image guided biopsies of transplanted lung. - Provide image guided biopsies for use in future research of ex vivo biomarkers of BOS and in the development of treatments through future clinical trials. The study will achieve these aims through a prospective, non-randomized, longitudinal, observational study that will recruit about 5 subjects a year for 5 years. The study will follow these post lung transplant patients at 6 months and 1 year with 129Xe MRI (Hyperpolarized 129Xenon Magnetic Resonance Imaging) and image guided bronchial biopsies to detect early BOS and to better understand BO disease progression. The biopsies will provide future research for rapid determination of cellular and molecular mechanisms that lead to BOS and to facilitate identification and validation of translatable pharmaceutical targets. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03603899
Study type Interventional
Source Children's Hospital Medical Center, Cincinnati
Contact Carrie Stevens, BS
Phone (513) 636-9973
Email carrie.stevens@cchmc.org
Status Recruiting
Phase Phase 1/Phase 2
Start date September 9, 2020
Completion date October 2027
View Details
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