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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
Sponsor:
Collaborator:
Philips Healthcare
Information provided by:
VU University Medical Center

Tracking Information
First Submitted Date February 26, 2010
First Posted Date March 1, 2010
Last Update Posted Date November 2, 2012
Study Start Date April 2010
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 26, 2010)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: February 26, 2010)
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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Virtual Bronchoscopy Transbronchial Needle Aspiration(TBNA): a Proof of Concept Study
Official Title CT-PET Virtual Bronchoscopy Guided Transbronchial Needle Aspiration for Mediastinal Lymph Node Staging in Suspected Lung Cancer
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.
Detailed 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.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with suspected lung cancer requiring mediastinal lymph node staging after CT-PET scan during routine work-up according to local guidelines.
Condition Lung Cancer
Intervention Other: Virtual Bronchoscopy Navigation
Use of dedicated virtual bronchoscopy navigation software using 4D CT-PET scan spacial data.
Study Groups/Cohorts Suspected mediastianl lymph nodes
Patients with (suspected) lung cancer requiring MLN staging after CT-PET during routine work-up according to existing staging guidelines.
Intervention: Other: Virtual Bronchoscopy Navigation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: February 26, 2010)
80
Original Estimated Enrollment Same as current
Actual Study Completion Date May 2011
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number NCT01077492
Other Study ID Numbers 09/327
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party T.G. Sutedja, MD, PhD, VU University Medical Center
Study Sponsor VU University Medical Center
Collaborators Philips Healthcare
Investigators
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
PRS Account VU University Medical Center
Verification Date February 2010