Virtual Bronchoscopy Transbronchial Needle Aspiration(TBNA): a Proof of Concept Study
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ClinicalTrials.gov Identifier: NCT01077492 |
Recruitment Status :
Terminated
First Posted : March 1, 2010
Last Update Posted : November 2, 2012
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Condition or disease | Intervention/treatment |
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Lung Cancer | Other: Virtual Bronchoscopy Navigation |
Study Type : | Observational |
Actual Enrollment : | 80 participants |
Observational Model: | Case-Only |
Time Perspective: | Prospective |
Official Title: | CT-PET Virtual Bronchoscopy Guided Transbronchial Needle Aspiration for Mediastinal Lymph Node Staging in Suspected Lung Cancer |
Study Start Date : | April 2010 |
Actual Primary Completion Date : | May 2011 |
Actual Study Completion Date : | May 2011 |

Group/Cohort | Intervention/treatment |
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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.
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Other: Virtual Bronchoscopy Navigation
Use of dedicated virtual bronchoscopy navigation software using 4D CT-PET scan spacial data. |
- Feasibility of VB in determining N2/N3 mediastinal lymph nodes [ Time Frame: 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.
- 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. [ Time Frame: 1 year ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01077492
Netherlands | |
VU University Medical Center | |
Amsterdam, Netherlands, 1081 HV |
Study Chair: | Sayed Hashemi, MD | VU University Medical Center | |
Study Chair: | Hans Daniels, MD | VU University Medical Center | |
Study Chair: | Emiel Comans, PhD | VU University Medical Center | |
Study Chair: | Otto Hoekstra, PhD | VU University Medical Center | |
Study Chair: | Piet Postmus, PhD | VU University Medical Center | |
Principal Investigator: | Tom Sutedja, PhD | VU University Medical Center |
Responsible Party: | T.G. Sutedja, MD, PhD, VU University Medical Center |
ClinicalTrials.gov Identifier: | NCT01077492 |
Other Study ID Numbers: |
09/327 |
First Posted: | March 1, 2010 Key Record Dates |
Last Update Posted: | November 2, 2012 |
Last Verified: | February 2010 |
lung cancer mediastinal lymph nodes TBNA staging lung cancer |
Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases |