跳至主要内容
临床试验/NCT03290183
NCT03290183Unknown不适用

Confocal Laser Endomicroscopy in Pleural Malignancies: A Comparison With Pathology

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2017年8月28日最近更新:
适应症

试验速览

阶段
不适用
入组人数
20
试验地点
2
主要终点
Procedure-related adverse events

研究概览

简要总结

To date, the different biopsy methods, such as CT-guided pleural biopsy, mediastinal biopsy, endosonography and thoracoscopy have their limitations in diagnosing pleural malignancies, such as mesothelioma. Sampling errors frequently occur resulting in the common histological finding of 'non-specific pleuritic/fibrosis', which presents a great uncertainty for clinicians and patients. Confocal laser endomicroscopy (CLE) provides real-time imaging on a cellular level, however data of CLE in pleural malignancies are lacking.

详细描述

Novel optical imaging techniques such as confocal laser endomicroscopy (CLE) have emerged in recent years as techniques that actually enable in vivo real-time microscopic analysis of malignancies of the GI-tract and lung cancer. Through recent advances the probe became small enough to fit through a biopsy needle and can be used during CT-guided and endosonographic guided biopsies (EUS-FNA). Patients with intra-thoracic malignancies often require invasive procedures such as bronchoscopy, thoracoscopy, mediastinoscopy, transthoracic needle aspiration or surgical exploration to obtain a diagnosis. Intra thoracic malignancies encompass lung cancers, thymomas and malignant pleural mesothelioma. These tumors often present with pleural thickening, unilateral pleural effusion, mediastinal enlargement or a peripheral located mass in the lungs. Tissue collection of the suspected pleural thickening is required to assess a diagnosis and differentiate between the tumor types, to classify and to stage in a proper manner. To date, the different biopsy methods, such as CT-guided pleural biopsy, mediastinal biopsy, endosonography and thoracoscopy have their limitations in diagnosing these malignancies. Sampling errors frequently occur resulting in the common histological finding of 'non-specific pleuritic/fibrosis', which presents a great uncertainty for clinicians and patients. Novel microscopic imaging techniques such as CLE are capable of real time imaging on a cellular level. Data of CLE in intra-thoracic malignancies are lacking.

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

入选标准

  • ≥18 years of age
  • Supected intra-thoracic malignancies with pleural involvement and referred for a diagnostic procedure by thoracoscopy, CT guided biopsy or endosonography

排除标准

  • Inability and willingness to provide informed consent
  • Patients with known allergy for fluorescein or risk factors for an allergic reaction
  • pregnancy or lactating women

结局指标

主要结局

Procedure-related adverse events

时间窗: cross sectional (1 day)

Number of study-related adverse events

To describe and develop visual descriptive image criteria (number of descriptive criteria based on CLE imaging)

时间窗: cross sectional (1 day)

Qualitative description of the number of descriptive criteria based on CLE imaging.

Technical feasibility: Number of successful procedures with evaluable CLE-imaging

时间窗: cross sectional (1 day)

Number of successful procedures with evaluable CLE-imaging

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof J.T. Annema

Head of pulmonary endoscopy department

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

研究点 (2)

Loading locations...

相似试验