title: Irreversible electroporation (IRE) fails to demonstrate efficacy in a prospective multicenter phase II trial on lung malignancies: the ALICE trial.
abstract: OBJECTIVE
  To assess safety and efficacy of irreversible electroporation (IRE) of lung malignancies.
  
  
  METHODS
  Patients with primary and secondary lung malignancies and preserved lung function were included in this prospective single arm trial. Primary and secondary endpoints were safety and efficacy. Recruitment goal was 36 subjects in 2 centers. Patients underwent IRE under general anesthesia with probe placement performed in Fluoroscopy-CT. The IRE system employed was NanoKnife® (Angiodynamics). System settings for the ablation procedure followed the manufacturer's recommendations. The Mann-Whitney U test was used to evaluate the correlation of nine technical parameters with local tumor control. Median follow up was 12 months.
  
  
  RESULTS
  The expected efficacy was not met at interim analysis and the trial was stopped prematurely after inclusion of 23 patients (13/10 between both centers). The dominant tumor entity was colorectal (n = 13). The median tumor diameter was 16 mm (8-27 mm). Pneumothoraces were observed in 11 of 23 patients with chest tubes required in 8 (35 %). Frequently observed alveolar hemorrhage never led to significant hemoptysis. 14/23 showed progressive disease (61 %). Stable disease was found in 1 (4 %), partial remission in 1 (4 %) and complete remission in 7 (30 %) patients. The relative increase of the current during ablation was significantly higher in the group treated successfully as compared to the group presenting local recurrence (p < 0.05). Needle tract seeding was found in three cases (13 %).
  
  
  CONCLUSIONS
  IRE is not effective for the treatment of lung malignancies. We hypothesize that the energy deposition with current IRE probes is highly sensitive to air exposure.
authors.affiliation: Department of Radiology and Nuclear Medicine, University of Magdeburg, Leipziger Strasse 44, 39120, Magdeburg, Germany, jens.ricke@med.ovgu.de.
authors.forename: Jens
authors.initials: J
authors.lastname: Ricke
authors.forename: Julian H W
authors.initials: JH
authors.lastname: Jürgens
authors.forename: Frederic
authors.initials: F
authors.lastname: Deschamps
authors.forename: Lambros
authors.initials: L
authors.lastname: Tselikas
authors.forename: Katja
authors.initials: K
authors.lastname: Uhde
authors.forename: Ortrud
authors.initials: O
authors.lastname: Kosiek
authors.forename: Thierry
authors.initials: T
authors.lastname: De Baere
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018274:Electroporation / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008168:Lung; D008175:Lung Neoplasms / Q000000981:diagnostic imaging / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D015641:Radiography, Interventional / Q000379:methods; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome