The Efficacy and Safety of Irreversible Electroporation for the Ablation of Renal Masses: A Prospective, Human, In-Vivo Study.

Phase 2

Withdrawn

Conditions: renal cancer
renal cell carcinoma
10038364

Registration Number: NL-OMON40514

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

- Age * 18 years
- Solid, enhancing mass on cross sectional imaging
- Scheduled for a radical nephrectomy (open or laparoscopic)

Exclusion Criteria

- Irreversible bleeding disorders
- Inability/unwillingness to interrupt anticoagulation therapy
- Previous cryoablation, RFA or partial nephrectomy in affected kidney
- Anasthesia Surgical Assignment (ASA), category * IV
- ICD / pacemaker
- Severe cardiovascular disease in medical history

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. The efficacy of IRE ablation of renal masses, measured by histopathologic<br /><br>examination of the target tumour by an experienced genitourinary pathologist.<br /><br>Using immunehistochemical staining to evaluate cell viability.<br /><br><br /><br>2. The safety of IRE ablation of renal masses, by evaluating device and<br /><br>procedural adverse events using CTCAE v4.0.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- The efficacy of MRI in the imaging of ablation success, extend of the<br /><br>ablation zone, one and three weeks post IRE ablation. By comparing MRI imaging<br /><br>to the histopathological examination results of the resected material.<br /><br><br /><br>- The efficacy of CEUS in the imaging of ablation success, extend of the<br /><br>ablation zone, one and three weeks post IRE ablation. By comparing CEUS imaging<br /><br>to the histopathological examination results of the resected material.</p><br>