The DIRECT Study supports a proposed expanded indication for the NanoKnife System in the treatment of Stage III pancreatic cancer. The first patient enrollment closely follows the U.S. Food and Drug Administration’s (FDA) springtime approval of AngioDynamics’ investigational device exemption (IDE) application.
“The enrollment of our first patient soon after receiving FDA approval is a strong signal that clinicians are eager to evaluate treatment alternatives that improve the dismal prognosis for Stage III pancreatic cancer patients,” said Brent Boucher, AngioDynamics senior vice president and general manager of Oncology. “We look forward to confirming that our proprietary NanoKnife technology offers a compelling alternative to the current standard of care and believe that this study will provide a pivotal dataset for claims and reimbursement purposes.”
AngioDynamics’ DIRECT clinical study features a comprehensive data collection strategy that will provide meaningful clinical information to healthcare professionals, support a regulatory indication for the treatment of Stage III pancreatic cancer, and facilitate reimbursement for hospitals and treating physicians. The next-generation study is classified as a Category B IDE by the FDA, which allows participating sites to obtain coverage for procedures performed in addition to any related routine costs.
“We are pleased to be the first enrolling site. The DIRECT Study represents an important milestone in the standardization of care for patients with Stage III pancreatic cancer. Our goal is to generate important data that should standardize and optimize the use of IRE in the treatment of locally advanced pancreatic cancer, significantly improving outcomes for patients with this late-stage diagnosis,” said Dr. Robert C.G. Martin, co-principal investigator of the DIRECT Study and surgical oncologist at the University of Louisville.
The DIRECT Study comprises a Randomized Controlled Trial at up to 15 sites, as well as a Real-World Evidence, next-generation registry at up to 30 sites, each with a NanoKnife System treatment arm and a control arm. AngioDynamics expects each NanoKnife arm to consist of approximately 250 patients with an equal number of control patients. The primary endpoint of the study is overall survival.
As part of the DIRECT Study, AngioDynamics launched AngioDIRECT.com to facilitate the enrollment of participants. The online platform provides patients and their families with information about pancreatic cancer and details about the study. It also features a physician locator to help prospective participants and referring healthcare professionals identify clinical study locations.
There are approximately 57,000 new cases and 46,000 estimated deaths from pancreatic cancer in the United States annually.1 Total deaths due to pancreatic cancer are projected to increase dramatically to become the second leading cause of cancer-related deaths before 2030.2 The mortality rate is high due to the aggressive nature of the disease and lack of early warning signs, and less than 20 percent of patients are candidates for surgical resection at time of diagnosis.3 Approximately 35 percent to 40 percent of patients will present with Stage III and 45 to 55 percent with metastatic disease.3 Regardless of the stage of pancreatic cancer, it is one of the least survivable cancers, and survival rates have not improved substantially for more than 40 years.3 For all stages combined, the five-year relative survival rate is 8 percent and, for those with advanced disease at the time of diagnosis, the five-year survival rate remains at 3 percent.3
AngioDynamics Inc. provides minimally invasive medical devices used by professional healthcare providers for vascular access, peripheral vascular disease, and oncology. AngioDynamics’ product lines include ablation systems, fluid management systems, vascular access products, angiographic products and accessories, drainage products, thrombolytic products and venous products.
The NanoKnife System has received FDA 510(k) clearance for the surgical ablation of soft tissue. The NanoKnife Ablation System utilizes low energy direct current electrical pulses to permanently open pores in target cell membranes. These permanent pores, or nano-scale defects, in the cell membranes result in cell death. The treated tissue is then removed by the body's natural processes in a matter of weeks, mimicking natural cell death. Unlike other ablation technologies, the NanoKnife Ablation System does not achieve tissue ablation using thermal energy.
The NanoKnife Ablation System consists of two major components: a Low Energy Direct Current, or LEDC Generator and needle-like electrode probes. Up to six electrode probes can be placed into or around the targeted soft tissue. Once the probes are in place, the user enters the appropriate parameters for voltage, number of pulses, interval between pulses, and the pulse length into the generator user interface. The generator then delivers a series of short electric pulses between each electrode probe. The energy delivery is hyperechoic and can be monitored under real-time ultrasound.
The NanoKnife System is approved for commercialization in Canada, the European Union, and Australia. The NanoKnife System has not been cleared for the treatment or therapy of a specific disease or condition.
1 American Cancer Society. (2019). Cancer Facts & Figures. Retrieved March 14th, 2019, from https://www.cancer.org/cancer/pancreatic-cancer/about/key-statistics.html
2 Projecting Cancer Incidence and Deaths to 2030: The Unexpected Burden of Thyroid, Liver, and Pancreas Cancers in the United States. Lola Rahib, Benjamin D. Smith, Rhonda Aizenberg, Allison B. Rosenzweig, Julie M. Fleshman and Lynn M. Matrisian DOI: 10.1158/0008-5472.CAN-14-0155 https://www.ncbi.nlm.nih.gov/pubmed/24840647
3 American Society of Clinical Oncology. (2019). Pancreatic Cancer: Statistics. Retrieved March 14th, 2019, from https://www.cancer.net/cancer-types/pancreatic-cancer/statistics