A minimally invasive treatment option may change treatment options for patients with pancreatic cancer. The development of significantly more effective treatment options is possible as a result of an endoscopy tool created by a team at the Penn State Department of Mechanical Engineering.

The location of the pancreas in the abdomen and the difficulty to detect the disease make it one of the most difficult to treat.

A potentially curative surgery, which is currently the most-effective option in treating pancreatic cancer patients. However, this approach is only used when the results of exams and tests suggest that it?s possible to resect the complete cancer.

Most pancreatic cancers are unresectable at the time of diagnosis, and even in case of a resectable cancer, for elderly or patients with coexistent comorbidities, surgery is not an option. Furthermore, potentially curative surgery is only available if the surgeon is convinced that all of the cancer can be safely and completely removed. The key reason is that, according to the American Cancer Society, removing only part of a pancreatic cancer doesn?t help patients live longer.[1]

Photo 1.0: Brad Hanks works with the newly-developed custom electrode in Penstate’s Engineering Design and Optimization Group (EDOG) Lab.

In the end, only an average of about 20% of pancreatic cancer patients are eligible for a surgical resection of their tumor.

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Changing prognosis
To change the prognosis and outcome for pancreatic cancer patients, Brad Hanks, a doctoral student studying mechanical engineering, created a new type of electrode to be used in endoscopic radiofrequency ablation (RFA), which uses heat to destroy of unwanted tissue, is a well-established treatment for several benign, premalignant, and malignant disorders.[2]

Hank’s work in the Engineering Design and Optimization Group (EDOG), which will be presented at the upcoming 2019 Design of Medical Devices Conference to be helpd in Minneapolis, Minnesota, April 15-18, 2019, has been theorized to effectively neutralize 55% more of an abdominal tumor using RFA methods.[3]

Minimally invasive
A minimally invasive procedure, RFA is conducted by inserting an electrode into the abdomen and administering high-frequency energy that heats the tumor and as a result, neutralizes the cancer cells. While the RFA treatment itself is well-established and effective, the current endoscopic tools that exist to perform this procedure are ?one size fits all?, rather than customized to each person?s tumor.

A standard RFA electrode produces an elliptical ablation zone, which most tumors are approximately spherical. Since the RFA treatment zone doesn?t usually match the shape of the tumor, the untreated remnants can continue the spread of the disease.

?It?s like trying to fit a square peg in a round hole,? Hanks noted. ?Without a surgical tool to match the shape of the tumor, the effectiveness of the treatment can be severely limited,? he added

However, by harnessing finite element analysis and evolutionary algorithms, he designed an electrode that deploys once it is within the abdomen, spreading electrode ?fingers? that produce an ablation zone that is better matched to the specific tumor?s shape.

?Because each cancer patient is unique, I believe the tools we use to treat them should be as well,? he said.

Though the electrode itself may not able to completely eradicate the tumor, the method also provides additional benefits to a patients? on-going treatment, an idea from Hank?s collaborator on the project, Matthew T. Moyer, MD, MS, a physician at the Penn State Hershey Medical Center.

Current approach
Currently, gold beads called fiducials are often inserted in another procedure to provide guidance for radiation treatments. Marking the edges of the tumor through X-rays, the fiducials provide a clearer outline for targeting and eradicating the tumor. The custom electrode, designed to detach and stay in the tumor, can provide a similar purpose.

With one less procedure, “Using my electrodes, which are able to do the same thing, it?s a simplified process to have this electrode guide the way for radiologists,” Hank said.

In addition, with further exploration, Hanks hopes he can 3D print patient-specific electrodes to ensure an even more targeted and personalized treatment.

While he is still working on finding the perfect biomedical materials, Hanks hopes to leverage the facilities and expertise of Penn State?s additive manufacturing and design program (AMD) in this project.

?It adds another really interesting component to this work, it could lead to an even more custom treatment that is less expensive for the patient,? Hank said, who is earning a minor in AMD concurrently with his mechanical engineering degree.

While the initial focus of the project was on treating pancreatic cancer tumors due to the low rate of patients eligible for surgery and its status as the 4th most deadly cancer in the United States, the custom electrode treatment can be adapted for other abdominal cancers, including tumors found in the lungs and stomach.

Hanks became interested in the concept of creating innovative endoscopic tools. The impact his work could have on cancer patients is what initially drew Hanks not only to the project, but to the medical field itself.

?I seriously considered becoming a doctor while I was earning my bachelor?s degree,? Hank said.

?But I also like the building and designing aspect of engineering ? being able to blend the two fields is so exciting to me,? he added.

Going to market
The product is currently in development with Actuated Medical, a company based in Bellefonte, Pennsylvania that develops next-generation FDA-compliant medical devices. Hanks continues to conduct some testing of the product in the EDOG lab and mentor undergraduate students participating in the project, but has largely passed the baton to Kevin A. Snook, the medical transducer design leader and senior research engineer at Actuated Medical, to bring the device to market.

?We are very pleased to partner with Actuated Medical, Inc. to develop this device. Their expertise in manufacturing of medical devices is a great compliment to the modeling and optimization work that we are developing at Penn State,? observed Mary Frecker, Ph.D, professor of mechanical engineering and Hanks? adviser, observed.

?We help support the company with simulations and experiments and having a partner in industry has been a great experience,? Hanks said. ?I?m hopeful that patients will one day be able to benefit.?

?The day we are able provide truly personalized care for these cancers is not so far away,? he added.

Future treatment
Newer indications may provide definitive treatment, palliation, or alternative therapies for a wide variety of gastrointestinal and hepatopancreatobiliary pathologies.

However, despite being a feasible and safe modality, the high costs associated with RFA may limit the expanded applications.

[1] Alvarez-S?nchez MV, Napol?on B. Review of endoscopic radiofrequency in biliopancreatic tumours with emphasis on clinical benefits, controversies and safety. World J Gastroenterol. 2016 Oct 7;22(37):8257-8270.
[2] Becq A, Camus M, Rahmi G, de Parades V, Marteau P, Dray X. Emerging indications of endoscopic radiofrequency ablation. United European Gastroenterol J. 2015 Aug;3(4):313-24. doi: 10.1177/2050640615571159.
[3] McCarty TR, Rustagi T. New Indications for Endoscopic Radiofrequency Ablation.Clin Gastroenterol Hepatol. 2018 Jul;16(7):1007-1017. doi: 10.1016/j.cgh.2017.10.023. Epub 2018 Jan 17.

Last Editorial Review: January 30, 2019

Featured Image: Doctor in white medical lab coat points ballpoint pen on anatomical model of human or animal pancreas. Courtesy: ? 2010 ? 2019 Fotolia. Used with permission. Photo 1.0:?Brad Hanks works with the newly-developed custom electrode in the EDOG Lab. Courtesy: ? 2010 ? 2019 Erin Cassidy Hendrick. Used with permission.

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