跳至主要内容
临床试验/NCT02081092
NCT02081092已完成不适用

Evaluation and Treatment Planning of Patients With PAP Using Thrive Ultra Short Echo Time MRI and CT

Children's Hospital Medical Center, Cincinnati1 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2013年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
9
试验地点
1
主要终点
Comparing MRI's images pre and post whole lung lavage

研究概览

简要总结

The purpose of this study is twofold: to assess routine cat scan (CT) imaging as a biomarker for removal of lipoprotein surfactant via lung lavage (where CT is the gold-standard imaging technique for density quantification), and to utilize a novel UTE MRI protocol to similarly quantify surfactant removal. This study will also serve to generate baseline scanning that may aid in developing analytical tools to evaluate and treat specific lung regions of patients with PAP.

详细描述

This study will evaluate x-ray CT as a biomarker for surfactant lavage removal and evaluate an UTE-Thrive MRI protocol at CCHMC as an imaging alternative to CT. Potential subjects who meet study criteria will be identified by the Pulmonary physicians at Cincinnati Children's Hospital Medical Center (CCHMC) and University of Cincinnati (UC) through their clinic patients. The study will include two research MRIs (one pre lavage and the second 24 to 72 hours after the first lung lavage) and if there is a clinical CT performed pre lavage, then one research CT will also be performed with the second research MRI. All image analysis will be quantitative. Whole-lung and regional density will be calculated and evaluated before and after lung lavage, for a quantification of changes in density in the left lung and right lung separately. Since the one lung will serve as control, it will allow precise error estimation (which we expect to be quite small and largely related to differences in lung volume). One purpose of this protocol is to further refine and develop ultra-short echo time (UTE) MRI techniques since Pulmonary Alveolar Proteinosis (PAP) patients may have multiple lavage sessions per year. A subject may be eligible to re-enroll to participate multiple times if the total number of research CTs for all enrollments is one or less for that subject.

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
8 Years 至 75 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinically diagnosed PAP scheduled for lung lavage with double lumen endoscopy.
  • Children patients ≥ 8 years of age
  • Adult patients ≤ 75 years of age
  • Medically stable as per the opinion of Bruce Trapnell, MD or Robert Wood, MD
  • Patient and or parent consent obtained

排除标准

  • Standard MRI exclusion criteria as set forth by the CCHMC Division of Radiology
  • Pregnancy

结局指标

主要结局

Comparing MRI's images pre and post whole lung lavage

时间窗: 24 hours before lung lavage and 24-48 hours after lung lavage

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)

Loading locations...

相似试验