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
1 other identifier
observational
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 26, 2010
CompletedFirst Posted
Study publicly available on registry
March 1, 2010
CompletedStudy Start
First participant enrolled
April 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedNovember 2, 2012
February 1, 2010
1.1 years
February 26, 2010
November 1, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
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
Study Arms (1)
Suspected mediastianl lymph nodes
Patients with (suspected) lung cancer requiring MLN staging after CT-PET during routine work-up according to existing staging guidelines.
Interventions
Use of dedicated virtual bronchoscopy navigation software using 4D CT-PET scan spacial data.
Eligibility Criteria
Patients with suspected lung cancer requiring mediastinal lymph node staging after CT-PET scan during routine work-up according to local guidelines.
You may qualify if:
- 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
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amsterdam UMC, location VUmclead
- Philips Healthcarecollaborator
Study Sites (1)
VU University Medical Center
Amsterdam, 1081 HV, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Sayed Hashemi, MD
Amsterdam UMC, location VUmc
- STUDY CHAIR
Hans Daniels, MD
Amsterdam UMC, location VUmc
- STUDY CHAIR
Emiel Comans, PhD
Amsterdam UMC, location VUmc
- STUDY CHAIR
Otto Hoekstra, PhD
Amsterdam UMC, location VUmc
- STUDY CHAIR
Piet Postmus, PhD
Amsterdam UMC, location VUmc
- PRINCIPAL INVESTIGATOR
Tom Sutedja, PhD
Amsterdam UMC, location VUmc
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 26, 2010
First Posted
March 1, 2010
Study Start
April 1, 2010
Primary Completion
May 1, 2011
Study Completion
May 1, 2011
Last Updated
November 2, 2012
Record last verified: 2010-02