An observational study in Lung Cancer, sponsored by Amsterdam UMC, location VUmc. Terminated at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-11-02.
Sponsored by Amsterdam UMC, location VUmc · Observational
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.
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.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 80 is below the median of 189 across 1,514 observational studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Amsterdam UMC, location VUmc is the lead sponsor of 302 studies on the registry; 84 are open to participants now.
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Patients with suspected lung cancer requiring mediastinal lymph node staging after CT-PET scan during routine work-up according to local guidelines.
Exclusion Criteria:
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
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.
Time frame: 1 year
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
This study is terminated, as verified in Feb 2010. You cannot join it, but the record below documents what was studied.
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Amsterdam UMC, location VUmc