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J. Flandes



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    MA05 - Innovative Techniques in Pulmonology and the Impact on Lung Cancer (ID 378)

    • Event: WCLC 2016
    • Type: Mini Oral Session
    • Track: Pulmonology
    • Presentations: 1
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      MA05.02 - Electromagnetic Navigation Bronchoscopy: A Prospective, Global, Multicenter Analysis of 1000 Subjects with Lung Lesions (ID 4643)

      16:00 - 17:30  |  Author(s): J. Flandes

      • Abstract
      • Presentation
      • Slides

      Background:
      Electromagnetic navigation bronchoscopy (ENB) may aid in accessing smaller, more peripheral lesions and hence facilitate earlier diagnosis. ENB may also provide a safer alternative to transthoracic biopsy, and allow adequate tissue capture for molecular testing, diagnosis, staging, and localization for surgery in a single anesthetic event. However, usage patterns, safety, and performance remain largely unexplored in a prospective, multicenter study.

      Methods:
      NAVIGATE is a global, prospective, multicenter study of ENB using the superDimension™ navigation system (Medtronic, Minneapolis). A pre-specified 1-month interim analysis was conducted on the first 1,000 primary cohort subjects enrolled at 29 centers in the United States and Europe. Enrollment and 2-year follow-up are ongoing.

      Results:
      One-month follow-up was completed in 933/1,000 subjects. Of 1,000 procedures, ENB was intended for lung biopsy in 96.4%, to place fiducial markers in 21.0%, and for dye marking in 1.7% (multiple indications in 34.9%). Lymph node biopsies were attempted in 33.4% of procedures (322/334 using linear endobronchial ultrasound [EBUS]). General anesthesia was used in 79.7% and radial EBUS in 54.3%. Among 1,129 lung lesions, fluoroscopy was used in 90.1% and rapid on-site pathology evaluation in 683/1035 (66.0%). Median lesion size was 20.0 mm (interquartile range 16.0 mm). Most lesions were in the peripheral (62.6%) or middle (30.1%) lung thirds. A bronchus sign was present in 48.4% and 6.3% were ground glass. Navigation was subjectively considered successful in 1,036 lesions (91.8%). Site-reported pathology results were read as malignant in 452 lesions (43.6%), including 38.1% with primary lung cancer. Of 247 lesions with adenocarcinoma or unspecified non-small-cell lung cancer, 70 (28.3%) were sent for molecular testing with adequate tissue in 56/70 (80.0%). Primary lung cancer clinical stage was 52.9% I; 10.7% II, 18.9% III, and 17.3% IV. Preliminary non-malignant results were obtained in 444 lesions (42.9%). An additional 140 lesions (13.5%) were read as inconclusive. Longer follow-up is required to calculate the true negative rate and diagnostic yield. ENB-related pneumothorax was 4.9% (49/1,000) overall and 3.2% Grade ≥2 based on the Common Terminology Criteria for Adverse Events scale. The ENB-related Grade ≥2 bronchopulmonary hemorrhage and Grade ≥4 respiratory failures rates were 1.0% and 0.6%.

      Conclusion:
      Interim 1-month results suggest a low adverse event rate in the largest prospective, multicenter ENB study conducted to date. Continued enrollment and 2-year follow-up will elucidate the real-world utilization patterns, diagnostic yield, factors contributing to successful diagnosis, and the impact of ENB on lung cancer management.

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    P2.05 - Poster Session with Presenters Present (ID 463)

    • Event: WCLC 2016
    • Type: Poster Presenters Present
    • Track: Radiotherapy
    • Presentations: 1
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      P2.05-034 - New 3D «All in 1» Device for Fiducial Tumor Marking: A Pilot Animal Study (ID 3887)

      14:30 - 15:45  |  Author(s): J. Flandes

      • Abstract

      Background:
      Malignant lung lesions are commonly treated with stereotactic body radiotherapy e.g. Cyberknife®. However, a common problem of existing markers is migration which requires placement of several devices (usually 3). This study presents the results of a first animal evaluation of a new device that comprises several markers in a single implant device, which can be placed in a one-step bronchoscopic procedure.The purpose of the study was to demonstrate feasibility of a new « All in 1 » shape memory (Novatech[®]) Nitinol (Ni–Ti) device with Tantalum (Ta) markers, with safety and efficacy as key points, in a porcine model.

      Methods:
      Devices: 55 devices with 3 different shapes were used to determine the best design to reduce the migration risk. Animals: 2 series with a total of 8 Piétrain pigs, 5 animals for safety and 3 animals for efficacy evaluation using flexible bronchoscopy under general anesthesia. Follow-up period: 4 weeks. Image based analysis: CT scans pre- and post-procedure, after 2 and 4 weeks. Procedure: The markers where launched in different peripheral sub-segments using a radial EBUS guide sheath (Olympus® K-201) under fluoroscopy control. Evaluation: Procedure time, ease of placement, blinded CT scan analyses for evaluation of migration, complications and histological analysis.

      Results:
      All 55 devices were easily inserted into the peripheral bronchi. All devices could be visualized under fluoroscopy. The average procedure time was 5 min (+/- 2,6). 5 devices per animal were inserted in the first series and 10 devices per animal in the second series. During the 4 weeks clinical follow up and CT evaluation, no immediate or late complication occurred (pneumothorax, pneumonia, severe granulations or bleedings) in the first series. One partial (<20%) pneumothorax with spontaneous remission occurred in the second series due to forceful reintubation of the pig after accidental extubation. Migration has been seen in some pigs of the first series but not in the second series. No device related complications have been noted.

      Conclusion:
      In this pilot animal study the new « all in 1 » device for fiducial tumor marking was easy, quick and safe to use. It could be demonstrated that migration risk can be reduced with the right design.