title: Irreversible Electroporation for the Ablation of Renal Cell Carcinoma: A Prospective, Human, In Vivo Study Protocol (IDEAL Phase 2b).
abstract: BACKGROUND
  Irreversible electroporation (IRE) is an emerging technique delivering electrical pulses to ablate tissue, with the theoretical advantage to overcome the main shortcomings of conventional thermal ablation. Recent short-term research showed that IRE for the ablation of renal masses is a safe and feasible treatment option. In an ablate and resect design, histopathological analysis 4 weeks after radical nephrectomy demonstrated that IRE-targeted renal tumors were completely covered by ablation zone. In order to develop a validated long-term IRE follow-up study, it is essential to obtain clinical confirmation of the efficacy of this novel technology. Additionally, follow-up after IRE ablation obliges verification of a suitable imaging modality.
  
  
  OBJECTIVE
  The objectives of this study are the clinical efficacy and safety of IRE ablation of renal masses and to evaluate the use of cross-sectional imaging modalities in the follow-up after IRE in renal tumors. This study conforms to the recommendations of the IDEAL Collaboration and can be categorized as a phase 2B exploration trial.
  
  
  METHODS
  In this prospective clinical trial, IRE will be performed in 20 patients aged 18 years and older presenting with a solid enhancing small renal mass (SRM) (≤4 cm) who are candidates for ablation. Magnetic resonance imaging (MRI) and contrast-enhanced ultrasound (CEUS) will be performed at 1 day pre-IRE, and 1 week post-IRE. Computed tomography (CT), CEUS, and MRI will be performed at 3 months, 6 months, and 12 months post-IRE.
  
  
  RESULTS
  Presently, recruitment of patients has started and the first inclusions are completed. Preliminary results and outcomes are expected in 2018.
  
  
  CONCLUSIONS
  To establish the position of IRE ablation for treating renal tumors, a structured stepwise assessment in clinical practice is required. This study will offer fundamental knowledge on the clinical efficacy of IRE ablation for SRMs, potentially positioning IRE as ablative modality for renal tumors and accrediting future research with long-term follow-up.
  
  
  BACKGROUND
  Clinicaltrials.gov registration number NCT02828709; https://clinicaltrials.gov/ct2/show/NCT02828709 (archived by WebCite at http://www.webcitation.org/6nmWK7Uu9). Dutch Central Committee on Research Involving Human Subjects NL56935.018.16.
authors.affiliation: Academic Medical Center, Department of Urology, University of Amsterdam, Amsterdam, Netherlands.
authors.forename: Mara
authors.identifier: http://orcid.org/0000-0001-6768-0483
authors.initials: M
authors.lastname: Buijs
authors.affiliation: Academic Medical Center, Department of Radiology, University of Amsterdam, Amsterdam, Netherlands.
authors.forename: Krijn P
authors.identifier: http://orcid.org/0000-0001-7102-2213
authors.initials: KP
authors.lastname: van Lienden
authors.affiliation: Academic Medical Center, Department of Urology, University of Amsterdam, Amsterdam, Netherlands.
authors.forename: Peter Gk
authors.identifier: http://orcid.org/0000-0003-1756-0461
authors.initials: PG
authors.lastname: Wagstaff
authors.affiliation: Academic Medical Center, Department of Urology, University of Amsterdam, Amsterdam, Netherlands.
authors.forename: Matthijs Jv
authors.identifier: http://orcid.org/0000-0002-9098-9574
authors.initials: MJ
authors.lastname: Scheltema
authors.affiliation: Academic Medical Center, Department of Biomedical Engineering and Physics, University of Amsterdam, Amsterdam, Netherlands.
authors.forename: Daniel M
authors.identifier: http://orcid.org/0000-0003-3047-3637
authors.initials: DM
authors.lastname: de Bruin
authors.affiliation: Academic Medical Center, Department of Urology, University of Amsterdam, Amsterdam, Netherlands.
authors.forename: Patricia J
authors.identifier: http://orcid.org/0000-0003-0812-078X
authors.initials: PJ
authors.lastname: Zondervan
authors.affiliation: Academic Medical Center, Department of Radiology, University of Amsterdam, Amsterdam, Netherlands.
authors.forename: Otto M
authors.identifier: http://orcid.org/0000-0003-3342-9367
authors.initials: OM
authors.lastname: van Delden
authors.affiliation: Academic Medical Center, Department of Biomedical Engineering and Physics, University of Amsterdam, Amsterdam, Netherlands.
authors.forename: Ton G
authors.identifier: http://orcid.org/0000-0002-5642-1133
authors.initials: TG
authors.lastname: van Leeuwen
authors.affiliation: Academic Medical Center, Department of Urology, University of Amsterdam, Amsterdam, Netherlands.
authors.forename: Jean Jmch
authors.identifier: http://orcid.org/0000-0002-6308-1763
authors.initials: JJ
authors.lastname: de la Rosette
authors.affiliation: Academic Medical Center, Department of Urology, University of Amsterdam, Amsterdam, Netherlands.
authors.forename: M Pilar
authors.identifier: http://orcid.org/0000-0003-0906-4417
authors.initials: MP
authors.lastname: Laguna
keywords: IRE; ablation; cancer; efficacy; irreversible electroporation; kidney; renal cell carcinoma; safety