Imaging of Human Epithelial Airway Using a High Resolution Micro OCT Catheter (Functional Anatomic Imaging of CF Patients With Early Lung Disease Using Micro OCT)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- feasibility of uOCT probe
研究概览
简要总结
The purpose of this study is to learn about using the imaging to make images of the lungs and nose with the long-term goal of the research leading to potential treatments and new therapies for patients with cystic fibrosis.
详细描述
Lung Disease is the predominate cause of morbidity and mortality in patients with cystic fibrosis (CF). A better understanding of the primary pathogenesis of CF is essential in order to reveal the features that may lead to the onset of progressive lung disease. Discerning the nature of the CF defect could resolve longstanding controversy and result in a new therapeutic opportunity that may address pathophysiology. Recently the investigators have developed an innovative technology, termed 1-µm resolution optical coherence tomography (µOCT), which enables real-time cross-sectional microscopy of the functional epithelial surface of living airways.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •THE INCLUSION CRITERIA:
- •Patients diagnosed with CF or healthy normal controls with no respiratory disease
- •Patients must be over the age of 14
- •Patient must be able to give informed consent
排除标准
- •Patients with recent respiratory infection requiring antibiotics or corticosteroids in the last 4 weeks (excluding routine perioperative antibiotics)
- •Patients with major sinus surgery that will alter the nasal anatomy and preclude imaging of the nares
- •Any condition that in the opinion of the investigator will alter the safety of pilot testing in the operating room
- •Female subjects who are pregnant
结局指标
主要结局
feasibility of uOCT probe
时间窗: 1 year
to determine if a uOCT probe can image airway epithelial cells from the lung and the nares of adult patients
次要结局
未报告次要终点
研究者
Steven M Rowe
Principal Investigator
University of Alabama at Birmingham