SBIR-STTR Award

Both primary and metastatic liver cancer is common in the US, and worldwide. The standard treatment for liver cancer is liver resection, where part of the liver containing the tumor is surgically removed. Surgery is however only possible in ~20% of the patients, and Radiofrequency (RF) ablation is an accepted treatment method for patients where surgery is not possible. During RF ablation, an electrode is introduced into the tumor, and the cancer is destroyed by heating via RF current. Current RF ablation procedures have several shortcomings resulting in often insufficient treatment: (1) an inability to adequately treat even moderate sized tumors (>3.0 cm) with a single ablation, (2) inadequate performance close to large vessels, and (3) inadequate intraoperative imaging. We propose a new tumor ablation device that consists of an array of electrodes surrounding the tumor and directing bipolar energy from outside, instead of heating the tumor inside-out, as with current ablation devices. The device with circumferential electrodes will generate a more uniform, higher temperature profile in the treated tumor and overcome the cooling effect of vessels within the liver. Furthermore, the device will allow rapid treatment of large tumors with a single application which is not possible with current devices. This will make treatment planning considerably less complex, reducing procedure time for large tumor treatment, and likely also lower tumor recurrence rate, increasing the survival. Ablation time will be significantly reduced from currently 12-45 min to below 5 min. In addition, complications such as skin burns due to heating of dispersive electrodes and tumor seeding along needle insertion tracts will be avoided.

Public Health Relevance:
The device proposed in this project will, if successful, allow more effective treatment of liver cancer patients not treatable by surgery, reducing treatment times and ultimately improving patient survival.

Public Health Relevance:
This Public Health Relevance is not available.

Thesaurus Terms:
There Are No Thesaurus Terms On File For This Project.

Both primary and metastatic liver cancer is common in the US, and worldwide. The standard treatment for liver cancer is liver resection, where part of the liver containing the tumor is surgically removed. This operation is associated with considerable blood loss, typically between 0.6 - 1 L. Blood loss is adversely associated with patient morbidity and survival, particularly when blood transfusions are required. We have developed a liver resection device that allows coagulation of a plane of liver tissue within 3 min, including major vessels. The device consists of a linear array of electrodes, to which radiofrequency (RF) energy is applied in bipolar fashion between neighboring electrodes. This liver resection device has the potential of reducing blood loss during liver resection surgery to a minimum, with likely increase in patient survival and lowered complication rates. If resection is not possible, tumors are often directly treated by heat- based thermal ablation. Based on the same blade electrode platform, we have in addition developed a prototype circumferential electrode array that allows rapid direct treatment of large tumors, with sufficient advantages in terms of efficacy compared to current available devices. Both types of the electrode arrays are driven by a multi-channel radiofrequency generator (RFG). The output of this RFG is modulated based on measurements of the tissue impedance, which allows us to account for differences in tissue thickness and determine when the tissue has been sufficiently coagulated/ablated. In this project we will produce a clinical prototype RFG and circumferential electrode array suitable for human use, and perform preclinical animal studies. Based on early prototype studies, it is expected that these new devices will lower health care costs and reduce morbidity and mortality.

Public Health Relevance Statement:


Public Health Relevance:
We will develop a system for assisting liver cancer treatment during surgery and for use during localized thermal therapy. Our device will, if successful, reduce blood loss during liver surgery to a minimum, and allow rapid treatment of large tumors. This will likely result in reduced complications due to bleeding during surgery and increase patient survival rates. It will lower health care costs and reduce morbidity and mortality.

Project Terms:
Ablation; Accounting; Algorithmic Software; Animal Model; Animals; Area; base; Blood Transfusion; bone; Caliber; cancer cell; cancer therapy; Cell Death; Clinical; clinical application; Coagulation Process; comparative efficacy; Complication; design; Development; Devices; Disseminated Malignant Neoplasm; Documentation; electric impedance; Electrodes; Evaluation; Excision; Family suidae; Gold; Hand; Health; Health Care Costs; Heating; Hemorrhage; Hepatectomy; High temperature of physical object; Human; Image; in vivo; intraoperative imaging; Kidney; Laparoscopy; Liver; Lung; Malignant neoplasm of liver; Measurement; Methods; Morbidity - disease rate; Mortality Vital Statistics; operation; Operative Surgical Procedures; Output; Patients; Performance; perfusion (blood); pre-clinical; prototype; Puncture procedure; Radiation therapy; radiofrequency; Radiofrequency Interstitial Ablation; Recurrence; Shapes; Site; Slice; standard care; Surgeon; Survival Rate; System; Technology; Temperature; Thermal Ablation Therapy; Thick; Time; Tissues; treatment planning; tumor