Center for Surgical Innovation receives FDA approval for new research

The Dartmouth

October 27, 2016

By Alexandra Pattillo

Last week, a research team from the Dartmouth Center for Surgical Innovation received Food and Drug Administration approval to explore the use of a new fluorescent agent in neurosurgical procedures. Led by biomedical engineering professor Keith Paulsen and neurosurgery professor and primary clinical investigator David Roberts, this study is the first to involve human subjects and could potentially transform neurosurgery.

Known as ABY-029, the agent binds to epithelial growth receptors within tumor tissue. When exposed to a particular light during surgery, the agent fluoresces, enabling surgeons to more accurately distinguish between healthy tissue and cancerous tissue. Paulsen, who is also the project leader for Dartmouth’s Center for Surgical Innovation said that if successful, this study could significantly improve clinical outcomes.

“In a primary brain tumor, tumor tissue growing in the brain looks exactly like normal brain tissue,” Paulsen said. “It’s not like it has a different color or texture, so it is really difficult to differentiate what is normal brain tissue and what isn’t, especially in malignant tumors. And of course in the brain, there is so much critical function. A millimeter matters.”

The Center for Surgical Innovation is focused on improving the efficacy and safety of surgery without the time and cost constraints that typically exist in an operating room. The facility opened in 2013, with two operating rooms, and two procedure rooms and is equipped with advanced technology: CT, MRI, fluoroscopy, robotics and surgical navigation.

With FDA approval, the research team at CSI is studying the use of the agent as a diagnostic tool, not as a form of therapy.

“This is a small, first-in-human surgical series that will hopefully show that such a strategy for identifying tumors intraoperatively is feasible and safe, laying the groundwork for subsequent larger trials that will look at such clinical outcomes as more complete tumor resection, longer survival and lower morbidity,” Roberts said.

Paulsen and Roberts noted that surgeons are incredibly receptive to new developments in the field, especially in neurosurgery, where decision-making is critical and often occurs with significant uncertainty.

“Unlike a drug trial or an imaging trial where you can pretty much predict what you want to do and it happens the same every time, in surgery, there’s always something unique, or interesting or different about every case,” Paulsen said. “Surgeons are always having to adapt and solve a particular challenge.”

This research stems from a long-standing collaborative relationship between the College, Thayer School of Engineering, Geisel School of Medicine and Dartmouth-Hitchcock Medical Center. For the past decade, researchers have been exploring another type of fluorescence-based guidance, and this new study is an extension of that research using a new agent.

The research team plans to recruit one human subject per month over the next year or so, specifically focusing on patients with malignant gliomas, tumors in the brain or spinal cord.

“There are very real implications for the larger field of medicine because the concept of such molecular targeting is hardly restricted to intracranial applications,” Roberts said. “Such strategies will likely be applicable to tumors almost anywhere in the body.”

The new agent, if successful, would most effectively be used on tumors overexpressing the epithelial growth factor, such as cancers in the head, neck and extremities.

“This research has the opportunity to significantly advance the ability to safely and effectively operate on people with malignant brain tumors,” Roberts said. “That’s incredibly meaningful to anyone working in the field of cancer surgery, and the novel aspect of the strategy employed makes it especially interesting.”

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