September 17, 2019 by John Fernandez
Milestone Nanoknife Trial Focuses on Late-Stage Pancreatic Cancer
Last year, the U.S. Food and Drug Administration (FDA) granted “breakthrough designation” — or an accelerated path — for the technology known as NanoKnife to be studied in treating late-stage pancreatic cancer, an area of special interest to Govindarajan Narayanan, M.D., chief of interventional oncology at Miami Cancer Institute.
Dr. Narayanan has been researching NanoKnife’s role in pancreatic cancer for nearly a decade. Now comes the next phase: A landmark clinical trial to study the effectiveness of the NanoKnife in fighting pancreatic cancer, which makes up just 3 percent of cancers in the U.S. but it is particularly deadly. It accounts for 7 percent of deaths from cancer in the U.S.
Dr. Narayanan will serve as a co-principal investigator in the nationwide trial that represents a milestone in the care for patients with stage III pancreatic cancer. Both Miami Cardiac & Vascular Institute and the Miami Cancer Institute have been early adopters of the NanoKnife technology.
(Watch Now: The Baptist Health News Team hears from Govindarajan Narayanan, M.D., chief of interventional oncology at Miami Cancer Institute. Video by Carol Higgins.)
NanoKnife is a minimally invasive device used to treat focal prostate lesions through irreversible electroporation, which refers to the infusion of DNA or chromosomes into cells using a pulse of electricity. NanoKnife uses low-energy, direct-current electrical pulses to permanently open pores in target cell membranes. Today, NanoKnife therapy is primarily used for liver, kidney and gall bladder tumors.
The FDA’s green light last year meant that “there is potential for the technology in pancreatic cancer but they wanted more information,” explains Dr. Narayanan. Now the FDA has granted what is called an IDE, or “investigational device exemption,” a designation that the agency uses to collect vital data required before a pre-market approval is given. The approved clinical trial is “randomized controlled.” This type is considered the gold standard for a clinical trial because it randomly allocates patients to two or more groups, treating them differently. The researchers then seek to measure and compare the outcomes after the participants are treated. The randomization is meant to prevent skewing of results.
“So that took close to a year and the FDA has provided the IDE to conduct a randomized controlled trial in pancreatic cancer to study the efficacy and the safety of the Nanoknife and its role in pancreatic cancer,” says Dr. Narayanan. “So this is something which is very exciting. It’s been a long time but we’re finally there.”
Dr. Narayanan said his role in the clinical trial will be as co-principal investigator, along with Robert C.G. Martin, M.D., surgical oncologist at the University of Louisville.
“Pancreatic cancer has several dubious distinctions,” says Dr. Narayanan. “It is the most lethal cancer. The survival for these patients is very short and this is mostly because of the way the disease declares itself — it’s usually pretty late.
Most of pancreatic patients at the time of diagnosis are in the stage 4 category, representing about 50 percent of cases, he says.
“That means the tumor has already metastasized outside the pancreas and another high percentage of these patients — even though the tumor is confined to the pancreas — are considered stage 3, or locally advanced pancreatic cancer, and that’s another 30 to 40 percent,” explains Dr. Narayanan. “That leaves about 10 percent of these patients as surgical candidates.”
Patients in the clinical trial will be those classified as stage 3 who are not good surgical candidates, he says. The time allowed for patient enrollment is close to two years, and the follow-up will take another three years. The total study is projected to take about five years, he says. “I have watched randomized control trials happen in Europe, hoping that one day we will be able to do the same thing here,” says Dr. Narayanan. “It’s very exciting now to have the ability to do that in the United States and collect a very high level of data right here at home.”