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

NCT ID: NCT01077492

Last Updated: 2012-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-04-30

Study Completion Date

2011-05-31

Brief Summary

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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

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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

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Lung Cancer

Keywords

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lung cancer mediastinal lymph nodes TBNA staging lung cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Suspected mediastianl lymph nodes

Patients with (suspected) lung cancer requiring MLN staging after CT-PET during routine work-up according to existing staging guidelines.

Virtual Bronchoscopy Navigation

Intervention Type OTHER

Use of dedicated virtual bronchoscopy navigation software using 4D CT-PET scan spacial data.

Interventions

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Virtual Bronchoscopy Navigation

Use of dedicated virtual bronchoscopy navigation software using 4D CT-PET scan spacial data.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Philips Healthcare

INDUSTRY

Sponsor Role collaborator

Amsterdam UMC, location VUmc

OTHER

Sponsor Role lead

Responsible Party

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VU University Medical Center

Principal Investigators

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Sayed Hashemi, MD

Role: STUDY_CHAIR

Amsterdam UMC, location VUmc

Hans Daniels, MD

Role: STUDY_CHAIR

Amsterdam UMC, location VUmc

Emiel Comans, PhD

Role: STUDY_CHAIR

Amsterdam UMC, location VUmc

Otto Hoekstra, PhD

Role: STUDY_CHAIR

Amsterdam UMC, location VUmc

Piet Postmus, PhD

Role: STUDY_CHAIR

Amsterdam UMC, location VUmc

Tom Sutedja, PhD

Role: PRINCIPAL_INVESTIGATOR

Amsterdam UMC, location VUmc

Locations

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VU University Medical Center

Amsterdam, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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09/327

Identifier Type: -

Identifier Source: org_study_id