CT-PET virtual bronchoscopy guided transbronchial needle aspiration for mediastinal lymph node staging in suspected 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 minimal invasive strategies such as
esophageal ultrasound guided fine needle aspiration (EUS-FNA) and endobronchial
ultrasound guided TBNA (EBUS-TBNA) were introduced. These strategies have have
largely replaced TBNA and surgical staging, with high accuracy and low
morbidity. Disadvantages compared to TBNA however are higher equipment and
maintenance costs, the need for more assisting personel 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.

To determine whether CT-PET virtual bronchoscopy guided TBNA (CT-PET-VB guided
TBNA) is suitable for staging MLNs in patients with suspected LC.

Phase 1A: Feasibility trial in 40 patients to test the accuracy (i.e. true
positives and negatives) with a CT-PET-VB guided TBNA yield of at least 0.6.
For each patient 4R, 4L and station no 7 will be routinely punctured for MLNs
>15mm in size.
Phase 1B: Extension of the study in another 40 patients in whom CT-PETVB fusion
4D algorithms will be refined, to enhance accuracy of 0.8 for targeting MLNs
<15mm in size.

TBNA is a common procedure and not associated with serious complications. Minor
hemorrage may occur after passage of the needle through the airway.