Virtual Bronchoscopy Transbronchial Needle Aspiration(TBNA): a Proof of Concept Study

Terminated

• Conditions: Lung Cancer
• Interventions: Other: Virtual Bronchoscopy Navigation

• Registration Number: NCT01077492
• Lead Sponsor: Amsterdam UMC, location VUmc

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2010-02
• Study First Submitted: 2010-02-26
• Study First Submitted QC: 2010-02-26
• Study First Posted: 2010-03-01
• Study Start: 2010-04
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Last Update Submitted: 2012-11-01
• Last Update Posted: 2012-11-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• 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

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Suspected mediastianl lymph nodes	Virtual Bronchoscopy Navigation	Patients with (suspected) lung cancer requiring MLN staging after CT-PET during routine work-up according to existing staging guidelines.

Primary Outcome Measures

Name	Time	Method
Feasibility of VB in determining N2/N3 mediastinal lymph nodes	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.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

VU University Medical Center; 🇳🇱 Amsterdam, Netherlands