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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01077492
• Other study ID #: 09/327
• Status: Terminated
• Phase: N/A
• First received: February 26, 2010
• Last updated: November 1, 2012
• Start date: April 2010
• Est. completion date: May 2011

Study information

• Verified date: February 2010
• Source: VU University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 80
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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:

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Other:
• Virtual Bronchoscopy Navigation
Use of dedicated virtual bronchoscopy navigation software using 4D CT-PET scan spacial data.

Locations

Country	Name	City	State
Netherlands	VU University Medical Center	Amsterdam

Sponsors (2)

Lead Sponsor	Collaborator
VU University Medical Center	Philips Healthcare

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of VB in determining N2/N3 mediastinal lymph nodes	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.	1 year	No
Secondary	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	No