There’s big news for the 600,000 people in the U.S. who receive radiation therapy as part of cancer treatment each year. A tiny implantable device incubated at NC State and being commercialized by Sicel Technologies, Inc., may soon allow doctors to customize radiation treatments based on the patient’s own biological information and response to therapy. Such
targeted treatments are expected to decrease patient hospitalization and costs, and may well save more lives than today’s treatments.

The M-STAR DVS (dose verification system) is the result of an ideal combination of need and know-how. Dr. Charles Scarantino, a radiation oncologist at the Rex Healthcare Cancer Center, knew all about the need. Dr. Troy Nagle, an NC State professor of electrical engineering, provided the know-how.

Scarantino and Nagle first developed the concept for implantable oncology devices in 1997 and were granted the seminal patent for Sicel Technology’s products. “Oncologists need a monitoring method to provide continuous data on tumor physiology,” says Scarantino. Current procedures, such as biopsy, MRI and PET, can be invasive and costly—and the information gathered is only one snapshot in time. “We need to know things like the actual radiation dose hitting the tumor, the tumor temperature during hyperthermia treatment, the uptake and retention of chemotherapy drugs, and parameters like pH or oxygen,” he explains. “Sensors can provide doctors information so they can ensure proper dose control and protect healthy and sensitive surrounding tissue.”



Co-founded by Scarantino, Nagle, and the experienced entrepreneurial management team of Bob and Claudia Black, Sicel Technologies set up shop on NC State’s Centennial Campus in 1999. Today, the company has filed 11 patents, two of those owned jointly with NC State, and one licensed exclusively from NC State. With employment at 19 and significant expansion planned, Sicel has moved to larger labs and raised $7 million in investment capital, and is currently preparing for product launch and manufacturing ramp-up.
Initial focus is on the M-STAR DVS, which can be implanted into or around tumors using a minimally invasive injection device. The sensors will measure total dose during each of the dozens of radiation treatments for a typical patient, wirelessly transmitting their data to a hand-held monitor using radio frequency coupling.

With help from Dr. David Russlander at NC State’s College of Veterinary Medicine, Sicel’s first device was tested last year in animals. Pivotal trials on humans are in progress at Rex Healthcare, Duke University Medical Center, and additional sites. “These trials are demonstrating that the product is safe and that the technology works,” says Scarantino. “The next step will be to
determine whether, using the data provided by the sensor, oncologists can achieve better results by customizing patient treatments.”

Upon FDA approval, Sicel plans to sell the M-STAR DVS to a select group of 50 radiation oncology centers serving as proving grounds for the clinical utility of the sensor. “Beyond that,” says Claudia Black, Vice President of Operations and Finance, “the Sicel platform for implantable sensors to guide cancer therapy creates a global market in the $2 billion range.”

The Sicel vision is for many kinds of sensors, including one to measure uptake of radioactively labeled drugs, allowing the clinician to choose the most effective drug and determine its effect
on tumor metabolism. “Recently, a patient commented that he wished tumors could talk,” says Scarantino. “I think they can talk, and I think now for the first time, we’re going to be
able to listen.”

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