Safety and Feasibility of IRE for SRMs

Kidney Cancer Clinical Trial

Official title:

The Safety and Feasibility of Irreversible Electroporation for the Ablation of Small Renal Masses

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02828709
• Other study ID #: NL5693501816
• Status: Recruiting
• Phase: Phase 2
• First received: July 4, 2016
• Last updated: September 26, 2016
• Start date: July 2016
• Est. completion date: July 2019

Study information

• Verified date: September 2016
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: Mara Buijs, MD
• Phone: +31(0)205665793
• Email: m.buijs[@]amc.uva.nl
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: July 2019
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Cancer
• Kidney Neoplasms

Intervention

Device:
• Irreversible Electroporation
Guided by CT and accompanied by an external spacer for fixation, needle electrodes will be placed. The amount of probes and probe placement will be attuned for specific tumour size and location, granting 15mm between the electrodes with an active tip length of 15mm. IRE pulses with pulse intensity of 1500 V/cm will be delivered in 90 consecutive pulses of 90µs.

Locations

Country	Name	City	State
Netherlands	Academic Medical Center (AMC)	Amsterdam	Noord-Holland

Sponsors (2)

Lead Sponsor	Collaborator
Dr. Prof. M.P. Laguna Pes	Angiodynamics, Inc.

Country where clinical trial is conducted

Netherlands, 

References & Publications (7)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Wendler JJ, Ricke J, Pech M, Fischbach F, Jürgens J, Siedentopf S, Roessner A, Porsch M, Baumunk D, Schostak M, Köllermann 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	safety IRE ablation procedure (evaluating device and procedural adverse events using CTCAE v4.0)	To determine the safety and feasibility of IRE ablation of small renal masses (= 4cm), by evaluating device and procedural adverse events using CTCAE v4.0	2 years	Yes
Secondary	Clinical efficacy ((non-)presence of tumour enhancement on cross-sectional imaging post IRE)	To determine the clinical efficacy of IRE ablation of small renal masses (= 4cm), assessed by calculating recurrence and residual disease at follow-up, measured through the (non-)presence of tumour enhancement on cross-sectional imaging post IRE	2 years	No
Secondary	Cross sectional imaging post ablation	To evaluate the use of CT, MRI, and CEUS in the imaging of ablation success, extend of the ablation zone, 1 week, 3 months, 6 months, and 1 year post IRE	2 years	No
Secondary	Renal function	To evaluate the effect of RE ablation of small renal masses (= 4cm) on the renal function, measured by serum creatinine levels and estimated Glomerular Filtration Rate (eGFR)	2 years	No
Secondary	Average length of hospital stay	To evaluate the effect of IRE ablation of small renal masses (= 4cm) on the length of hospital stay, measured in average stay in days	2 years	No
Secondary	Quality of Life	To evaluate the effect of IRE ablation of small renal masses (= 4cm) on the quality of life, assessed through SF-36 questionnaires	2 years	No
Secondary	Postoperative pain score	To asses the effect of IRE ablation of small renal masses (= 4cm), assessed through VAS score and analgesics use	1 year	No