Clinical trial NCT01077492: 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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Lung Cancer
Keywords: lung cancer
mediastinal lymph nodes
TBNA
staging lung cancer
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
Collaborators: name: Philips Healthcare
First posted: 2010-03-01
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Feasibility of VB in determining N2/N3 mediastinal lymph nodes
timeFrame: 1 year
Secondary outcomes:
measure: 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.
timeFrame: 1 year
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: VU University Medical Center
Study officials:
affiliation: Amsterdam UMC, location VUmc
name: Sayed Hashemi, MD
role: STUDY_CHAIR
affiliation: Amsterdam UMC, location VUmc
name: Hans Daniels, MD
role: STUDY_CHAIR
affiliation: Amsterdam UMC, location VUmc
name: Emiel Comans, PhD
role: STUDY_CHAIR
affiliation: Amsterdam UMC, location VUmc
name: Otto Hoekstra, PhD
role: STUDY_CHAIR
affiliation: Amsterdam UMC, location VUmc
name: Piet Postmus, PhD
role: STUDY_CHAIR
affiliation: Amsterdam UMC, location VUmc
name: Tom Sutedja, PhD
role: PRINCIPAL_INVESTIGATOR
References: