Clinical trial NCT02828709: Safety and Feasibility of IRE for SRMs
Official title: The Safety and Feasibility of Irreversible Electroporation for the Ablation of Small Renal Masses
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Kidney Cancer
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: Angiodynamics, Inc.
First posted: 2016-07-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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. 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 tumours.

This is a prospective, human, in-vivo study among 20 patients presenting with solid enhancing SRM on cross sectional imaging suspect for renal cell carcinoma (RCC). Preoperatively, imaging is required through Magnetic Resonance Imaging (MRI), Contrast-enhanced ultrasound (CEUS) and contrast-enhanced Computed Tomography (CT). Furthermore, serum creatinine levels and VAS scores are obtained. A biopsy of the SRM will be performed in preoperative setting. IRE ablation will be performed using CT-guidance and ablation success will be measured directly after the ablation through contrast-enhanced CT. Device related adverse events (AE) will be registered using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 guideline. One week post ablation only CEUS and MRI will be performed to limit exposure to ionizing radiation. At 3 months, 6 months and 12 months post ablation CEUS, MRI and CT will be performed. Additionally, at these time points serum creatinine levels and VAS scores will be obtained, and quality of life will be assessed through SF-36 questionnaires. Residual and recurrent disease will be assessed through tissue enhancement on cross sectional imaging.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Solid, enhancing mass on cross sectional imaging
* Signed informed consent
* Candidate for focal ablative therapy

Exclusion Criteria:

* Irreversible bleeding disorders
* Inability/unwillingness to interrupt anticoagulation therapy
* Previous cryoablation, RFA or partial nephrectomy in affected kidney
* Anaesthesia Surgical Assignment (ASA), category ≤ IV
* ICD / pacemaker

Primary outcomes:
measure: safety IRE ablation procedure (evaluating device and procedural adverse events using CTCAE v4.0)
timeFrame: 2 years
Secondary outcomes:
measure: Clinical efficacy ((non-)presence of tumour enhancement on cross-sectional imaging post IRE)
timeFrame: 2 years
measure: Cross sectional imaging post ablation
timeFrame: 2 years
measure: Renal function
timeFrame: 2 years
measure: Average length of hospital stay
timeFrame: 2 years
measure: Quality of Life
timeFrame: 2 years
measure: Postoperative pain score
timeFrame: 1 year
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Academic Medical Center (AMC)
state: Noord-Holland
Study officials:
affiliation: Academic Medical Center (AMC) Amsterdam
name: Maria Pilar Laguna Pes, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thomson KR, Cheung W, Ellis SJ, Federman D, Kavnoudias H, Loader-Oliver D, Roberts S, Evans P, Ball C, Haydon A. Investigation of the safety of irreversible electroporation in humans. J Vasc Interv Radiol. 2011 May;22(5):611-21. doi: 10.1016/j.jvir.2010.12.014. Epub 2011 Mar 25.
citation: Wendler JJ, Ricke J, Pech M, Fischbach F, Jurgens J, Siedentopf S, Roessner A, Porsch M, Baumunk D, Schostak M, Kollermann J, Liehr UB. First Delayed Resection Findings After Irreversible Electroporation (IRE) of Human Localised Renal Cell Carcinoma (RCC) in the IRENE Pilot Phase 2a Trial. Cardiovasc Intervent Radiol. 2016 Feb;39(2):239-50. doi: 10.1007/s00270-015-1200-6. Epub 2015 Sep 4.
citation: Trimmer CK, Khosla A, Morgan M, Stephenson SL, Ozayar A, Cadeddu JA. Minimally Invasive Percutaneous Treatment of Small Renal Tumors with Irreversible Electroporation: A Single-Center Experience. J Vasc Interv Radiol. 2015 Oct;26(10):1465-71. doi: 10.1016/j.jvir.2015.06.028. Epub 2015 Aug 4.
citation: Pech M, Janitzky A, Wendler JJ, Strang C, Blaschke S, Dudeck O, Ricke J, Liehr UB. Irreversible electroporation of renal cell carcinoma: a first-in-man phase I clinical study. Cardiovasc Intervent Radiol. 2011 Feb;34(1):132-8. doi: 10.1007/s00270-010-9964-1. Epub 2010 Aug 15.
citation: van den Bos W, de Bruin DM, van Randen A, Engelbrecht MR, Postema AW, Muller BG, Varkarakis IM, Skolarikos A, Savci-Heijink CD, Jurhill RR, Zondervan PJ, Laguna Pes MP, Wijkstra H, de Reijke TM, de la Rosette JJ. MRI and contrast-enhanced ultrasound imaging for evaluation of focal irreversible electroporation treatment: results from a phase I-II study in patients undergoing IRE followed by radical prostatectomy. Eur Radiol. 2016 Jul;26(7):2252-60. doi: 10.1007/s00330-015-4042-3. Epub 2015 Oct 8.
citation: van den Bos W, Scheffer HJ, Vogel JA, Wagstaff PG, de Bruin DM, de Jong MC, van Gemert MJ, de la Rosette JJ, Meijerink MR, Klaessens JH, Verdaasdonk RM. Thermal Energy during Irreversible Electroporation and the Influence of Different Ablation Parameters. J Vasc Interv Radiol. 2016 Mar;27(3):433-43. doi: 10.1016/j.jvir.2015.10.020. Epub 2015 Dec 17.
citation: Wagstaff PG, de Bruin DM, van den Bos W, Ingels A, van Gemert MJ, Zondervan PJ, Verdaasdonk RM, van Lienden KP, van Leeuwen TG, de la Rosette JJ, Laguna Pes MP. Irreversible electroporation of the porcine kidney: Temperature development and distribution. Urol Oncol. 2015 Apr;33(4):168.e1-7. doi: 10.1016/j.urolonc.2014.11.019. Epub 2014 Dec 31.
citation: Buijs M, van Lienden KP, Wagstaff PG, Scheltema MJ, de Bruin DM, Zondervan PJ, van Delden OM, van Leeuwen TG, de la Rosette JJ, Laguna MP. Irreversible Electroporation for the Ablation of Renal Cell Carcinoma: A Prospective, Human, In Vivo Study Protocol (IDEAL Phase 2b). JMIR Res Protoc. 2017 Feb 16;6(2):e21. doi: 10.2196/resprot.6725.