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 inpancreatic cancer for nearly a decade. Now comes the next phase: A landmarkclinical trial to study the effectiveness of the NanoKnife in fightingpancreatic cancer, which makes up just 3 percent of cancers in the U.S. but itis particularly deadly. It accounts for 7 percent of deaths from cancer in theU.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 focalprostate lesions through irreversible electroporation, which refers to theinfusion of DNA or chromosomes into cells using a pulse of electricity.NanoKnife uses low-energy, direct-current electrical pulses to permanently openpores in target cell membranes. Today, NanoKnife therapy is primarily used forliver, kidney and gall bladder tumors.

The FDA’s green light last year meant that “there ispotential for the technology in pancreatic cancer but they wanted moreinformation,” explains Dr. Narayanan. Now the FDA has granted what iscalled an IDE, or “investigational device exemption,” a designationthat the agency uses to collect vital data required before a pre-marketapproval is given. The approved clinical trial is “randomized controlled.”This type is considered the gold standard for a clinical trial because itrandomly allocates patients to two or more groups, treating them differently.The researchers then seek to measure and compare the outcomes after theparticipants are treated. The randomization is meant to prevent skewing ofresults.

“So that took close to a year and the FDA has providedthe IDE to conduct a randomized controlled trial in pancreatic cancer to studythe efficacy and the safety of the Nanoknife and its role in pancreaticcancer,” says Dr. Narayanan. “So this is something which is veryexciting. It’s been a long time but we’re finally there.”

Dr. Narayanan said his role in the clinical trial will be asco-principal investigator, along with Robert C.G. Martin, M.D., surgicaloncologist at the University of Louisville.

“Pancreatic cancer has several dubiousdistinctions,” says Dr. Narayanan. “It is the most lethal cancer. Thesurvival for these patients is very short and this is mostly because of the waythe disease declares itself — it’s usually pretty late.

Most of pancreatic patients at the time of diagnosis are inthe stage 4 category, representing about 50 percent of cases, he says.

“That means the tumor has already metastasized outsidethe pancreas and another high percentage of these patients — even though thetumor is confined to the pancreas — are considered stage 3, or locallyadvanced pancreatic cancer, and that’s another 30 to 40 percent,” explainsDr. Narayanan. “That leaves about 10 percent of these patients as surgicalcandidates.”

Patients in the clinical trial will be those classified asstage 3 who are not good surgical candidates, he says. The time allowed forpatient enrollment is close to two years, and the follow-up will take anotherthree years. The total study is projected to take about five years, he says. “I have watched randomized control trialshappen in Europe, hoping that one day we will be able to do the same thinghere,” says Dr. Narayanan. “It’s very exciting now to have theability to do that in the United States and collect a very high level of dataright here at home.”