This Small Business Innovation Research (SBIR) Phase I project offers a substantial improvement in the surgical treatment of cancer. The inability to find malignant tissue by sight or touch limits the tissue that the surgeon can identify and remove. Currently, removal of affected tissue must be confirmed in the pathology laboratory resulting in delays of results for sometimes 24-36 hours. Some patients may be subjected to multiple surgeries for the complete removal of the cancerous tissue. NovaScan has developed a highly innovative, rapid and accurate criterion for detecting cancerous tissue using the tissue electrical properties of the tissues. This technology will be incorporated into a hand-held probe used by the surgeon to ascertain that the surgical wound and regional lymph nodes are clear of cancer.
The broader impacts of this research are related to reducing the number of repeat surgeries that increase the risk for the patient, and add a cost burden to our society at a time when we are trying to reduce health care costs. For breast cancer, one group has reported 48.5% of patients required more than one operation to removal the known cancer. In contrast to other methods under study, the proposed technology requires less time, no sample preparation, and does not employ the use of hazardous agents for tumor detection. Based on earlier studies, the NovaScan device offers a tool for the surgical suite or pathology laboratory that can detect tumor cells accurately and at lower costs than is currently available.
According to the America Cancer Society, an estimated 1.4 million Americans will be diagnosed with cancer this year with 560,000 deaths. Cancer treatment costs were over $72 billion in 2004, which was approximately 5% of the total U.S. spending for medical care. Between 1995 and 2004, the overall cost of treating cancer increased by 75 percent and it is expected to grow at a faster rate than overall medical expenditures. As the population ages, the absolute number of people treated for cancer will also rise and a recent report projects that the number of new cancer cases in the U.S. will grow by 45% over the next 20 years, with a "dramatic spike" predicted among elderly and minority populations. Cancer surgery, which is an operation to repair or remove part of the body to diagnose or treat cancer, remains the foundation of cancer treatment. The primary purpose of surgery is to cure cancer by physically removing it from the patient. The surgeon usually accomplishes this by cutting into the body and removing the cancer along with some surrounding tissue. Because the surgeon cannot see small collections of tumor cells, it is not until the pathologist has analyzed the tissue, which takes 24 hours or longer, is it determined if all of the cancer has been removed. The consequence is that many patients leave surgery still harboring dangerous tumor cells and another operation has to be performed to remove the cancer that was missed in the first procedure. This increases the risks to the patient and results in added costs due to the repeat surgery. NovaScan’s technology, embodied in the FastPath Surgical Probe, will provide surgeons with a unique tool to ensure that all of the cancer has been removed For breast cancer, the estimated number of new cancer cases annually is 180,510 with 40,910 deaths, making it one of the most common cancers for women. The number of lumpectomies (surgery to remove the tumor) performed each year in the U.S. is 159,000 and estimates of the number of re-surgeries required due to cancer missed during the initial operation are between 20% and 40%. At an average cost of $4,900 per lumpectomy operation, if the recall surgeries were eliminated that would translate into a potential annual savings to the healthcare system of $1 billion. This re-surgery problem occurs because currently the surgeon must wait for confirmation from microscope slides evaluated in the pathology lab that the tumor margins are clear and the extent of the involvement of adjacent lymph nodes. The standard pathology evaluations can take 20-30 minutes using frozen sections for lymph tissue while a patient is under anesthesia, to post-operative studies requiring 24-48 hours for tissue from the lump containing the tumor to be analyzed in the pathology laboratory.. If the surgeries must be repeated when the post-operative studies indicate missed malignant tissue, there is an increase of mortality and morbidity associated with the extra surgery and extended times under anesthesia. Even more serious is the recurrence of cancer because the current methods limit the amount of tissue that can be reasonably evaluated. These current procedures place the patient at a risk that the NovaScan device will substantially reduce or perhaps eliminate. During this Phase I NSF SBIR grant NovaScan has built and clinically tested a prototype hand-held device that will allow a surgeon to accurately and quickly determine whether all malignant tissue has been identified during cancer surgery. The device makes use of innovative measurements of the electrical properties of tissue. These measurements can be made rapidly (in fractions of a second) and, based on NovaScan’s current and previous studies, they yield accurate separation of cancerous from benign tissue, i.e. a sensitivity of 94% and a specificity of 83%. Beyond the high cost and the serious risk factors associated with the residual cancer problem, it is important to note that the reduction in surgeries that have to be repeated using the NovaScan FastPath device will give the patient more confidence that she will not have to undergo re-surgery, and the anxiety reduction of that benefit is a tremendous boon that cannot be quantified.
