Author of

• 17783

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

  • Event: WCLC 2016
  • Type: Poster Presenters Present
  • Track: Radiotherapy
  • Presentations: 1
  • Moderators:
  • Coordinates: 12/06/2016, 14:30 - 15:45, Hall B (Poster Area)

  • 17817

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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 - 14:30  |  Author(s): B. Escarguel
    • 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.