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
|Condition or disease||Intervention/treatment|
|Lung Cancer||Other: Virtual Bronchoscopy Navigation|
|Study Type :||Observational|
|Actual Enrollment :||80 participants|
|Official Title:||CT-PET Virtual Bronchoscopy Guided Transbronchial Needle Aspiration for Mediastinal Lymph Node Staging in Suspected Lung Cancer|
|Study Start Date :||April 2010|
|Primary Completion Date :||May 2011|
|Study Completion Date :||May 2011|
Suspected mediastianl lymph nodes
Patients with (suspected) lung cancer requiring MLN staging after CT-PET during routine work-up according to existing staging guidelines.
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 ]
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
|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|