ArticleJMIR research protocols2017
Irreversible Electroporation for the Ablation of Renal Cell Carcinoma: A Prospective, Human, In Vivo Study Protocol (IDEAL Phase 2b).
Article in JMIR research protocols, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02828709 (The Safety and Feasibility of Irreversible Electroporation for the Ablation of Small Renal Masses), which is not on this map. Cited by 10 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
The Safety and Feasibility of Irreversible Electroporation for the Ablation of Small Renal Masses
Who cites it
10 citing papers in PubMed, 18 citations in OpenAlex.
- MRI and CT in the follow-up after irreversible electroporation of small renal masses.Diagnostic and interventional radiology (Ankara, Turkey) · 2021Trial
- The growing armamentarium of image-guided tumor ablation in interventional oncology.Radiology advances · 2025Review
- Article
- Review
- Thermodynamic profiling during irreversible electroporation in porcine liver and pancreas: a case study series.Journal of clinical and translational research · 2020Article
- Percutaneous irreversible electroporation for the treatment of small renal masses: The first Canadian case series.Canadian Urological Association journal = Journal de l'Association des urologues du Canada · 2019Article
- Selective Inactivation ofAdvances in wound care · 2019Article
- Available ablation energies to treat cT1 renal cell cancer: emerging technologies.World journal of urology · 2019Review
- Time-Dependent Impact of Irreversible Electroporation on Pathology and Ablation Size in the Porcine Liver: A 24-Hour Experimental Study.Technology in cancer research & treatment · 2019Article
- Introducing new technology safely into urological practice.World journal of urology · 2018Review
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Authors and funding
10 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIrreversible 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.
objectiveThe 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.
methodsIn 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.
resultsPresently, recruitment of patients has started and the first inclusions are completed. Preliminary results and outcomes are expected in 2018.
conclusionsTo 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.
trial registrationClinicaltrials.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.
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