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临床试验/NCT02316392
NCT02316392已完成不适用

Imaging and Understanding BOS in Lung Transplantation

Children's Hospital Medical Center, Cincinnati1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2014年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
6
试验地点
1
主要终点
Analysis of MRI imaging to detect BOS compared to biopsy

研究概览

简要总结

This study is a prospective, non-randomized, longitudinal, observational study that will recruit about 5 lung transplant patients per year for 3 years.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
1 Year 至 25 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Lung Transplantation within the last 10 years or being assessed for possible lung transplantation.
  • Male or female
  • 0 to 25 years of age.

排除标准

  • 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

研究组 & 干预措施

Post transplant subjects

Hyperpolarized Helium-3 MRI. Subjects who have had or are scheduled to have a lung transplant

干预措施: Hyperpolarized Helium-3 MRI (Drug)

结局指标

主要结局

Analysis of MRI imaging to detect BOS compared to biopsy

时间窗: 3 years

Analysis of MRI imaging to detect BOS compared to biopsy

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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