Virtual Bronchoscopy Transbronchial Needle Aspiration(TBNA): a Proof of Concept Study
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.
|Study Design:||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|
- Feasibility of VB in determining N2/N3 mediastinal lymph nodes [ Time Frame: 1 year ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
|Study Start Date:||April 2010|
|Study Completion Date:||May 2011|
|Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|