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The efficacy and safety of irreversible electroporation for the ablation of renal masses: a prospective, human, in-vivo study protocol.

Wagstaff PG, de Bruin DM, Zondervan PJ, Savci Heijink CD, Engelbrecht MR, van Delden OM, van Leeuwen TG, Wijkstra H, de la Rosette JJ, Laguna Pes MP - BMC Cancer (2015)

Bottom Line: Electroporation is a novel treatment technique utilizing electric pulses, traveling between two or more electrodes, to ablate targeted tissue.Before progressing to a long-term IRE follow-up study it is vital to have pathological confirmation of the efficacy of the technique.MRI and CEUS imaging will be performed at baseline, one week and four weeks post IRE.

View Article: PubMed Central - PubMed

Affiliation: Department of Urology, Academic Medical Center, Meibergdreef 9, 1105AZ, Amsterdam, Netherlands. p.g.wagstaff@amc.nl.

ABSTRACT

Background: Electroporation is a novel treatment technique utilizing electric pulses, traveling between two or more electrodes, to ablate targeted tissue. The first in human studies have proven the safety of IRE for the ablation of renal masses. However the efficacy of IRE through histopathological examination of an ablated renal tumour has not yet been studied. Before progressing to a long-term IRE follow-up study it is vital to have pathological confirmation of the efficacy of the technique. Furthermore, follow-up after IRE ablation requires a validated imaging modality. The primary objectives of this study are the safety and the efficacy of IRE ablation of renal masses. The secondary objectives are the efficacy of MRI and CEUS in the imaging of ablation result.

Methods/design: 10 patients, age ≥ 18 years, presenting with a solid enhancing mass, who are candidates for radical nephrectomy will undergo IRE ablation 4 weeks prior to radical nephrectomy. MRI and CEUS imaging will be performed at baseline, one week and four weeks post IRE. After radical nephrectomy, pathological examination will be performed to evaluate IRE ablation success.

Discussion: The only way to truly assess short-term (4 weeks) ablation success is by histopathology of a resection specimen. In our opinion this trial will provide essential knowledge on the safety and efficacy of IRE of renal masses, guiding future research of this promising ablative technique.

Trial registration: Clinicaltrials.gov registration number NCT02298608 . Dutch Central Committee on Research Involving Human Subjects registration number NL44785.018.13.

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Related in: MedlinePlus

Study design flowchart.
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Fig1: Study design flowchart.

Mentions: This is a prospective, human, in-vivo study among 10 patients presenting with a solid renal mass, and candidates for radical nephrectomy (RN). A study flowchart is provided in Figure 1. Prior to the IRE procedure baseline MRI and CEUS imaging will be acquired. Subsequently the patients will undergo IRE ablation of their renal mass. Follow-up at one and four weeks post IRE will be performed using MRI and CEUS imaging. At these time points procedure and device related adverse events (AE) will be registered using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 guideline. Four weeks after IRE the patients will undergo radical nephrectomy after which pathological examination will be performed to evaluate IRE ablation success. Core biopsies are harvested before IRE ablation in order to assure tumour differentiation in case of complete ablation. Correlation between pathology and imaging will reveal the efficacy of MRI and CEUS for the assessment of IRE lesions.Figure 1


The efficacy and safety of irreversible electroporation for the ablation of renal masses: a prospective, human, in-vivo study protocol.

Wagstaff PG, de Bruin DM, Zondervan PJ, Savci Heijink CD, Engelbrecht MR, van Delden OM, van Leeuwen TG, Wijkstra H, de la Rosette JJ, Laguna Pes MP - BMC Cancer (2015)

Study design flowchart.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4376341&req=5

Fig1: Study design flowchart.
Mentions: This is a prospective, human, in-vivo study among 10 patients presenting with a solid renal mass, and candidates for radical nephrectomy (RN). A study flowchart is provided in Figure 1. Prior to the IRE procedure baseline MRI and CEUS imaging will be acquired. Subsequently the patients will undergo IRE ablation of their renal mass. Follow-up at one and four weeks post IRE will be performed using MRI and CEUS imaging. At these time points procedure and device related adverse events (AE) will be registered using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 guideline. Four weeks after IRE the patients will undergo radical nephrectomy after which pathological examination will be performed to evaluate IRE ablation success. Core biopsies are harvested before IRE ablation in order to assure tumour differentiation in case of complete ablation. Correlation between pathology and imaging will reveal the efficacy of MRI and CEUS for the assessment of IRE lesions.Figure 1

Bottom Line: Electroporation is a novel treatment technique utilizing electric pulses, traveling between two or more electrodes, to ablate targeted tissue.Before progressing to a long-term IRE follow-up study it is vital to have pathological confirmation of the efficacy of the technique.MRI and CEUS imaging will be performed at baseline, one week and four weeks post IRE.

View Article: PubMed Central - PubMed

Affiliation: Department of Urology, Academic Medical Center, Meibergdreef 9, 1105AZ, Amsterdam, Netherlands. p.g.wagstaff@amc.nl.

ABSTRACT

Background: Electroporation is a novel treatment technique utilizing electric pulses, traveling between two or more electrodes, to ablate targeted tissue. The first in human studies have proven the safety of IRE for the ablation of renal masses. However the efficacy of IRE through histopathological examination of an ablated renal tumour has not yet been studied. Before progressing to a long-term IRE follow-up study it is vital to have pathological confirmation of the efficacy of the technique. Furthermore, follow-up after IRE ablation requires a validated imaging modality. The primary objectives of this study are the safety and the efficacy of IRE ablation of renal masses. The secondary objectives are the efficacy of MRI and CEUS in the imaging of ablation result.

Methods/design: 10 patients, age ≥ 18 years, presenting with a solid enhancing mass, who are candidates for radical nephrectomy will undergo IRE ablation 4 weeks prior to radical nephrectomy. MRI and CEUS imaging will be performed at baseline, one week and four weeks post IRE. After radical nephrectomy, pathological examination will be performed to evaluate IRE ablation success.

Discussion: The only way to truly assess short-term (4 weeks) ablation success is by histopathology of a resection specimen. In our opinion this trial will provide essential knowledge on the safety and efficacy of IRE of renal masses, guiding future research of this promising ablative technique.

Trial registration: Clinicaltrials.gov registration number NCT02298608 . Dutch Central Committee on Research Involving Human Subjects registration number NL44785.018.13.

Show MeSH
Related in: MedlinePlus