TY - JOUR
T1 - Irreversible Electroporation for the Ablation of Renal Cell Carcinoma: A Prospective, Human, In Vivo Study Protocol (IDEAL Phase 2b)
AU - Buijs, Mara
AU - van Lienden, Krijn P.
AU - Wagstaff, Peter G. K.
AU - Scheltema, Matthijs J. V.
AU - de Bruin, Daniel M.
AU - Zondervan, Patricia J.
AU - van Delden, Otto M.
AU - van Leeuwen, Ton G.
AU - de La Rosette, Jean J. M. C. H.
AU - Laguna, M. Pilar
N1 - Publisher Copyright: © Mara Buijs, Krijn P van Lienden, Peter GK Wagstaff, Matthijs JV Scheltema, Daniel M de Bruin, Patricia J Zondervan, Otto M van Delden, Ton G van Leeuwen, Jean JMCH de la Rosette, M Pilar Laguna. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 16.02.2017. This is an open-access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org, as well as this copyright and license information must be included. Copyright: Copyright 2021 Elsevier B.V., All rights reserved.
PY - 2017
Y1 - 2017
N2 - 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
AB - 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
KW - Ablation
KW - Cancer
KW - Efficacy
KW - IRE
KW - Irreversible electroporation
KW - Kidney
KW - Renal cell carcinoma
KW - Safety
UR - http://www.scopus.com/inward/record.url?scp=85042440631&partnerID=8YFLogxK
U2 - https://doi.org/10.2196/resprot.6725
DO - https://doi.org/10.2196/resprot.6725
M3 - Article
C2 - 28209559
SN - 1929-0748
VL - 6
SP - e21
JO - JMIR research protocols
JF - JMIR research protocols
IS - 2
M1 - e21
ER -