跳至主要内容
临床试验/NCT01077492
NCT01077492终止不适用

CT-PET Virtual Bronchoscopy Guided Transbronchial Needle Aspiration for Mediastinal Lymph Node Staging in Suspected Lung Cancer

Amsterdam UMC, location VUmc1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2010年4月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
80
试验地点
1
主要终点
Feasibility of VB in determining N2/N3 mediastinal lymph nodes

研究概览

简要总结

The purpose of this study is to determine wether CT-PET virtual bronchoscopy guided transbronchial needle aspiration is suitable for the investigation of mediastinal lymph nodes which is needed for correct staging of lung cancer.

详细描述

Accurate staging of mediastinal lymph nodes (MLNs) in patients with lung carcinoma (LC) is paramount as the N stage largely determines treatment strategy, prognosis and outcome. Surgical staging such as mediastinoscopy is considered the gold standard. A less invasive alternative is transbronchial needle aspiration (TBNA). This technique is limited however by moderate and operator dependent accuracy. Recently less invasive strategies such as esophageal ultrasound guided fine needle aspiration (EUS-FNA) and endobronchial ultrasound guided TBNA (EBUS-TBNA) were introduced. These strategies have largely complemented TBNA and surgical staging, with high accuracy and low morbidity. Disadvantages compared to TBNA however are required specific expertise, higher equipment and maintenance costs, the need for more assisting personnel and the need for sedation. Advances in computer generated image processing based on available CT and PET images enable (quasi) real-time virtual bronchoscopy that can assist minimal invasive surgical performance including bronchoscopy. Optimizing the traditional TBNA procedure with these modern imaging techniques might be equally accurate and more cost effective.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age > 18 years
  • Proven or suspected lung cancer, base on clinical picture and/or CT-PET findings
  • Suspected involvement of mediastinal lymph nodes on CT-PET scan
  • Written informed consent

排除标准

  • 未提供

结局指标

主要结局

Feasibility of VB in determining N2/N3 mediastinal lymph nodes

时间窗: 1 year

Feasibility of virtual bronchoscopy in showing the presence or abscense of N2/N3 mediastinal lymph node (MLN) metastasis with accuracy of 0.6 in puncturing MLN \> 15 mm (CT images) and accuracy of 0.8 for MLN \< 15 mm in the second phase of the study.

次要结局

  • Duration of the session within the optimal time window of local anesthesia using lidocaine 1%; comparable to standard routine bronchoscopic procedure on an outpatient basis, i.e. not exceeding 30 minutes.(1 year)

研究者

发起方
Amsterdam UMC, location VUmc
申办方类型
Other

研究点 (1)

Loading locations...

相似试验