Safety and Feasibility of IRE for SRMs

Dr. Prof. M.P. Laguna Pes

Status and phase: Unknown; Phase 2

Conditions: Kidney Cancer

Treatments: Device: Irreversible Electroporation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02828709

NL5693501816

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Irreversible electroporation (IRE)

Experimental group

Description:

IRE is based on high current electric pulses, transferred between two or more placed needle electrodes. Charging the cell membrane causes holes in the cell membrane called "nanopores", resulting in increased permeability of the cell and subsequent cell death.

Treatment:

Device: Irreversible Electroporation