Choosing to participate in a clinical study is an important personal decision. Please speak with your doctor and/or family members about your treatment options.
To learn more about the DIRECT study, and if you or a loved one are eligible, your doctor may contact the study support team.
What is pancreatic cancer?
The pancreas is a gland located behind the stomach and in front of the spine. The pancreas’ function is to produce digestive enzymes and hormones that regulate blood sugar levels. Pancreatic cancer begins when abnormal, malignant (cancerous) cells form in the tissues of the pancreas3.
What is stage III pancreatic cancer?
In stage III pancreatic cancer, most tumors are unresectable (unable to be removed by surgery) and are treated with therapies that travel through the bloodstream to reach cancer cells throughout the body4.
Currently, the standard treatment options for stage III pancreatic cancer may include the following5:
- Palliative surgery or stent placement to bypass blocked areas in ducts or the small intestine
- Chemotherapy followed by chemoradiation
- Chemoradiation followed by chemotherapy
- Chemotherapy with or without targeted therapy
- A clinical trial of new anticancer therapies together with chemotherapy or chemoradiation
- A clinical trial of radiation therapy given during surgery or internal radiation therapy
What is Irreversible Electroporation (IRE)?
Irreversible Electroporation (IRE) is a technique in which electrical pulses are applied to cells that result in the formation of small defects in the cell membrane. After delivering a sufficient number of pulses, the cells are irreversibly damaged, thus resulting in 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.
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.
Our IRE technology is known as Nanoknife. A NanoKnife procedure is an ablation procedure that involves the delivery of a series of 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.
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