Electroporation Effective in Treating Hepatocellular Carcinoma

A planned phase 3 trial will enroll a further 25 patients with early-stage HCC at seven European centers; patients can have up to three tumors that are up to 3 cm in diameter each, and cannot be candidates for resection or transplantation. The primary endpoint is tumor response; secondary endpoints include safety, local recurrence, and overall survival.

Unlike radiofrequency ablation (RFA) or microwave techniques, IRE does not use thermal energy to kill tumor cells; instead, it uses electricity to break the cell membrane. The technique is cumbersome, requiring three electrodes and general anesthesia (GA) with muscle blockade, and uses a very high voltage (over 1,500 volts) to induce irreversible damage to cell membrane integrity, producing cell death. The placement of the needles is done under ultrasonography (US) or computed tomography (CT) imaging. Animal studies have shown that the area of ablation can be predicted precisely, thus preserving adjacent structures. The technique was presented at the 37th Annual VEITH Symposium, held during November 2010 in New York (NY, USA).

"This technique is promising. We have shown that tumors can be treated safety, and we can treat tumors that are in sites that are not ideal for RFA and microwave ablation,” said presenter Laura Crocetti, MD. "It is faster than RFA and microwave techniques, taking about 5 minutes for the entire procedure. The machine predicts the tumor volume and tells you the amount of voltage you need.”

The device under study is called the NanoKnife, a product of Angiodynamics (Latham, NY, USA), and is currently approved by the US Food and Drug Administration (FDA) for use in soft tissues alone. The NanoKnife uses direct current electrical fields to create nanoscale defects in the membranes of cells within a targeted soft tissue region; but although IRE effectively kills the tumors, it is unknown whether this translates to reduced recurrence or improved survival.

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