Imaging and Understanding BOS in Lung Transplantation
- Registration Number
- NCT02316392
- Lead Sponsor
- Children's Hospital Medical Center, Cincinnati
- Brief Summary
This study is a prospective, non-randomized, longitudinal, observational study that will recruit about 5 lung transplant patients per year for 3 years.
- Detailed Description
This study is a prospective, non-randomized, longitudinal, observational study that will recruit about 5 lung transplant patients per year for 3 years. We will follow these patients at 6 months and 1 year with Hyperpolarized Helium-3 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 6
- Lung Transplantation within the last 10 years or being assessed for possible lung transplantation.
- Male or female
- 0 to 25 years of age.
- Standard MRI exclusion criteria as set forth by the CCHMC Division of Radiology
- Inability to perform 10 second breath hold for 3He MRI scan
- Bleeding disorders
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Post transplant subjects Hyperpolarized Helium-3 MRI Hyperpolarized Helium-3 MRI. Subjects who have had or are scheduled to have a lung transplant
- Primary Outcome Measures
Name Time Method Analysis of MRI imaging to detect BOS compared to biopsy 3 years Analysis of MRI imaging to detect BOS compared to biopsy
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States