Clinical Trials Directory

Trials / Terminated

TerminatedNCT01077492

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

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

Status
Terminated
Phase
Study type
Observational
Enrollment
80 (actual)
Sponsor
Amsterdam UMC, location VUmc · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERVirtual Bronchoscopy NavigationUse of dedicated virtual bronchoscopy navigation software using 4D CT-PET scan spacial data.

Timeline

Start date
2010-04-01
Primary completion
2011-05-01
Completion
2011-05-01
First posted
2010-03-01
Last updated
2012-11-02

Locations

1 site across 1 country: Netherlands

Source: ClinicalTrials.gov record NCT01077492. Inclusion in this directory is not an endorsement.