What is the AngioDynamics DIRECT study?
DIRECT is a clinical study composed of two protocols that will evaluate the efficacy and safety of using IRE technology to ablate malignant pancreatic tumors in people diagnosed with stage III pancreatic cancer. The trial is set up to evaluate both real-world results from the Registry, and additional results from the Randomized Control Trial. The unique trial design is made possible by the use of Electronic Medical Record (EMR) technology to directly capture study data, thus reducing the burden on patients and clinicians.
Our IRE technology is known as Nanoknife. A NanoKnife procedure is an ablation procedure that involves the delivery of a series of high voltage direct current electrical pulses between electrodes placed within a target area of tissue. The NanoKnife System has been cleared by the FDA for the surgical ablation of soft tissue. It has not received clearance for the therapy or treatment of any specific disease or condition6.
The DIRECT study will evaluate the use of Nanoknife IRE technology on malignant tumors in the pancreas. If you are a physician and would like to get involved with the study, please contact our study support team.
What is Irreversible Electroporation (IRE)?
Irreversible Electroporation is a technique in which an electrical field is applied to cells in order to increase the permeability of the cell membranes through the formation of nanoscale defects in the lipid bilayer. After delivering a sufficient number of high voltage pulses, the cells surrounding the electrodes will be irreversibly damaged, thus resulting in systematic cell death. This mechanism which causes permanent cell damage is referred to as Irreversible Electroporation (IRE)6.
Our IRE technology is known as Nanoknife. The NanoKnife System has been cleared by the FDA for the surgical ablation of soft tissue. It has not received clearance for the therapy or treatment of any specific disease or condition.
1 American Cancer Society. (2019). Cancer Facts & Figures. Retrieved March 14th, 2019, from https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2019/cancer-facts-and-figures-2019.pdf
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, from 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
4 American Society of Clinical Oncology. (2019). Pancreatic Cancer: Stages. Retrieved March 15th, 2019, from https://www.cancer.net/cancer-types/pancreatic-cancer/stages
5 World Cancer Research Fund. Pancreatic cancer statistics: Pancreatic cancer is the 12th most common cancer worldwide. (2018). Retrieved March 14th, 2019, from https://www.wcrf.org/dietandcancer/cancer-trends/pancreatic-cancer-statistics
6 Global Cancer Statistics 2018: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries, Freddie Bray, BSc, MSc, PhD1; Jacques Ferlay, ME2; Isabelle Soerjomataram, MD, MSc, PhD3; Rebecca L. Siegel, MPH4; Lindsey A. Torre, MSPH5; Ahmedin Jemal, PhD, DVM6, from https://www.ncbi.nlm.nih.gov/pubmed/30207593
DIRECT Study Co-principal Investigators
Dr Robert C.G. Martin, MD, PhD, Surgical Oncology at the University of Louisville
Dr Govindarajan Narayanan, MD, Chief of Interventional Oncology at Miami Cancer Institute