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irreversible electroporation

nanoknife AngioDynamics US Ltd

Kai-Wen Huang, PhD

Liver cancer including primary hepatocellular carcinoma (HCC) and metastatic liver cancers is one the most common malignancies in the world. Over 10000 new cases per year are diagnosed in Taiwan. Despite the many treatment options, the prognosis of HCC remains dismal. More than 8000 people died of this cancer every year in Taiwan. A majority (70%to 85%) of patients present with advanced or unresectable disease. In contrast, small liver cancers can be cured with an appreciable frequency. Five-year disease-free survival exceeding 50% has been reported for surgical resection, and for the inoperable patients who do not have vascular invasion or extrahepatic spread. Radiofrequency ablation (RFA) is recommended as an alternative curative therapy. However, the main drawback of RFA is its limitation to tumor size and location. The tumors larger than 5 cm in diameter or located adjacent to vessels, could not be ablated completely.

Irreversible electroporation (IRE), developed and manufactured by AngioDynamics US Ltd, can ablate tumor by fenestrating the cancer cell membrane by electric pulse. The anti-tumor effect does not result from thermotherapy, so is also not diminished by adjacent vessels. Several pre-clinical studies have already demonstrated IRE is a safe and effective treatment for live cancers. The system has received CE mark approval in 2008 and FDA approval in 2010. However, there is no experience in using IRE fro tumor ablation in Taiwan. In this study, the investigators will perform intraoperative IRE for the patients with liver cancers who are scheduled to receive hepatectomy in our hospital, and the investigators will evaluate the ablate effect of tumors on specimens, and the effect of adjacent vessels. The investigators will appraisal the clinical feasibility and advantage of the system by this study.

Evaluation of Tumor Ablation Effects by Irreversible Electroporation for Patients With Malignant Liver Tumors

National Taiwan University Hospital

Symptoms and General Pathology

Neoplasm Metastasis

Colorectal Neoplasms

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Rectal Diseases

RF Ablation

Steven Strasberg, M.D.

* To determine the depth of coagulation which is possible in human liver tissue using the saline linked RF Surface ablation with the Tissue Link floating ball.
* To determine the efficacy of the technique on surface liver tumors using saline linked RF surface ablati
* To determine a safe (non-popping upper limit) of power per area that will permit a 1 cm depth of tissue destruction without inflow occlusion an da 2 cm depth with inflow occlusion.

Treatment Plan: Patients with resectable hepatic metastases confined to the liver and who are referred to the Study Chairs will undergo routine work-up for hepatic resection.

Operative Procedure:

Stage I will be completed and the data analyzed before Stage II commences. Stage I data will be used to define the safe levels for use in Stage II.

Stage I-Depth of coagulation with and without inflow occlusion at fixed times - and powers below the popping threshold.

At surgery, in the absence of extrahepatic disease, the liver will be dissected in the usual fashion for a bi-segmentectomy, hemihepatectomy or larger liver resection. Prior to transection of the liver, saline linked RF ablations will be performed on normal liver tissue within the area of resection away from the tumor and the proposed line of transection.

1 cm and 2 cm diameters will be studied together in 8 patients. They will be treated for a total of 18 minutes (9 min for 1 cm and 9 min for 2 cm with 9 minutes of inflow occlusion. The 4 cm lesions will be studied in 8 other patients, 4 of whom will receive 9 minutes of inflow occlusion.

After resection of the liver and establishment of resection margins on the tumor, the ablated areas of normal liver tissue will be excised frozen and studied for depth of lesion and examined by H \& E and histological techniques using vital stains that will allow definition of tissue depth.

Stage II-An ablate and resect Study

Once parameters have been defined on normal liver, the effect of surface RF ablation on resectable hepatic tumors which come to the surface of the liver will be examined. In this portion of the study, tumors will be treated with saline linked RF ablation with a power and a duration of application which has been found to produce the maximum safe depth of coagulation. The surface area of coagulation will be dependent upon the size of the tumor. The area of treatment will encompass the tumor as well as a zone at least 0.5cm outside the edge of the tumor. Inflow occlusion will be used in one half of the patients.

After resection of the liver and establishment of resection margins on the tumor, the ablated areas will be excised frozen and studied for depth of lesion and examined by H \& E and histological techniques using vital stains that will allow definition of tissue depth. Twelve tumors will be treated in 12 patients.

Pathology Evaluation

First Group of Patients The normal tissue exposed to RF will be resected, prepared for histo-pathological studies and examined to determine the extent of tissue necrosis and popping, if any.

Second Group of Patients Tumors exposed to RF ablation will be resected and the extent of tissue necrosis and popping will be determined. Also, damage to normal tissue will be examined.

Study of Saline Linked Monopolar Surface Radiofrequency (RF) Ablation of Hepatic Tumors

Phase I Study of Saline Linked Monopolar Surface Radiofrequency (RF) Ablation of Hepatic Tumors

Washington University School of Medicine

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluation of Tumor Ablation Effects by Irreversible Electroporation for Patients With Malignant Liver Tumors	NCT02010801	Malignant Liver...	irreversible el... nanoknife Angio...	18 Years -	National Taiwan University Hospital
Study of Saline Linked Monopolar Surface Radiofrequency (RF) Ablation of Hepatic Tumors	NCT00869843	Malignant Liver... Liver Metastase...	RF Ablation	18 Years -	Washington University School of Medicine
Evaluation of Tumor Ablation Effects by Irreversible Electroporation for Patients With Malignant Liver Tumors	NCT02010801	Malignant Liver...	irreversible el... nanoknife Angio...	18 Years -	National Taiwan University Hospital
Study of Saline Linked Monopolar Surface Radiofrequency (RF) Ablation of Hepatic Tumors	NCT00869843	Malignant Liver... Liver Metastase...	RF Ablation	18 Years -	Washington University School of Medicine
Evaluation of Tumor Ablation Effects by Irreversible Electroporation for Patients With Malignant Liver Tumors	NCT02010801	Malignant Liver...	irreversible el... nanoknife Angio...	18 Years -	National Taiwan University Hospital

Spots Global Cancer Trial Database for malignant liver tumors