Confocal Laser Endomicroscopy and OCT for Diagnosing ILD, a Comparison With Imaging and Pathology.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Describing visual characteristics on CLE-imaging and pOCT imaging of ILD.
研究概览
简要总结
Often, assessing a classifying diagnosis in patients with interstitial lung disease provides a diagnostic challenge. Currently HRCT, endoscopic or surgical video assisted thoracoscopic surgery(VATS) assessment including lung biopsies are diagnostic tools for patients with suspected ILD. However, tissue acquisition is associated with morbidity in these patients with an already compromised pulmonary function. In clinical practice this results in the fact that only a minor part of patients with an indication for tissue acquisition are actually undergoing biopsies. The aim of this study is to determine ILD-characteristics on imagign collected with minimal invasive novel optical techniques, to examine whether the addition of novel optical techniques to the diagnostic process of ILD could potentially limit the need for a tissue- (surgical) diagnosis and/or reduce the sampling error rate of biopsies by providing additional information on biopsy location.
详细描述
Novel probe based optical techniques such as Confocal laser endomicroscopy (pCLE) and Optical coherence tomography (pOCT) are non-invasive optical techniques, compatible with conventional diagnostic bronchoscopes and provide non-invasive, real-time information on the airway wall and the alveolar compartment. Therefore, immediate validation of optical measurements during a biopsy is possible. Optical techniques might either obviate the need for an tissue biopsy or improve the diagnostic yield of conventional biopsy methods and make surgical lung biopsies that are associated with high morbidity and costs redundant.
Hypothesis
Novel optical techniques (pCLE and pOCT) provide real time information about the characteristics of the mucosa and/or the alveolar compartment in ILD.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age
- •Supected ILD and referred for diagnostic bronchoscopic procedure with cryobiopsy
排除标准
- •Smoked in the last 6 months
- •Inability and willingness to provide informed consent
- •Inability to comply with the study protocol
结局指标
主要结局
Describing visual characteristics on CLE-imaging and pOCT imaging of ILD.
时间窗: cross sectional (1 day)
次要结局
- (um), size of the alveolar openings, number of cells on CLE imaging of the alveolar space (um).(cross-sectional (1 day))
- Size of the alveolar openings (um), thickness of the alveolar septum/alveolar openings on pOCT imaging of the alveolar compartment (um).(cross-sectional (1day))
- Feasibility of pOCT alveolar compartment: measuring number of alveoli, trajectory in OCT pull-back with alveoli (mm), number of study-related adverse events.(cross-sectional (1 day))
- Correlation between pOCT imaging and histology (alveolar septum-thickness and alveolar space (um))(cross-sectional (1 day))
- Correlation between pOCT imaging and histology (alveolar septum thickness (um) and alveolar compartment (mm)(cross-sectional (1 day))
研究者
Prof J.T. Annema
prof.dr. J.T. Annema
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)