It has been reported that physicians at VCU Massey Cancer Center in Richmond, VA are the first in the world to successfully implant a new bio-absorbable, internal radiation treatment known as CivaSheet® to treat a patient with resectable pancreatic cancer. Approximately 53,000 patients per year in the US are diagnosed with pancreatic cancer, and of those, approximately 13,000 will undergo surgical resection.
In March, a team of Massey cancer experts led by Emma Fields, M.D., radiation oncologist; Brian Kaplan M.D., surgical oncologist; and Dorin Todor, Ph.D., medical physicist, completed the procedure. A post-operative dosimetry study showed the radiation was effectively delivered, and no complications or radiation side effects have been reported.
“There has never been another bio-absorbable, unidirectional radiation therapy implant with shielding like the CivaSheet,” Fields said. “Pancreatic cancer really is a perfect malignancy for use of this device, because the cancer is in a very difficult location to treat with radiation, the risk of residual cancer cells following surgery is high, and the disease is very aggressive.”
Designed and manufactured by CivaTech Oncology, CivaSheet is a flexible, implantable intra-operative radiation therapy device (brachytherapy), which emits unidirectional radiation by integrating gold shielding. The unidirectional property makes the device active on one side only, and is entirely unique to CivaSheet. This allows physicians to safely deliver aggressive radiation doses immediately adjacent to healthy, sensitive tissue. Radiation is delivered as the isotope naturally decays over the course of several weeks – no repeated hospital trips are needed for radiation treatments. No follow-up procedure is necessary to remove the device.
The implementation of CivaSheet occurs during a pancreatic cancer resection. In a short 15-minute operating room procedure, the surgical team cuts the CivaSheet to fit and affixes it to the area they want to treat. CivaSheet delivers a highly-targeted radiation dose to the immediate area where residual cancer cells potentially remain. Massey physicians expect CivaSheet to minimize side effects and improve local control of pancreatic cancer. “It’s a win-win,” Fields said. “The CivaSheet does not alter how long a patient waits for surgery, or complicate the surgeon’s responsibilities during the procedure.”
The pancreas is located directly below the liver and behind the stomach. A portion of the small intestine, which is extremely sensitive to radiation, wraps around the head of the pancreas.
“The beauty of the unidirectional CivaSheet is you can place it face-down on the tissue that the tumor was resected from – where the intestines will lay. Because of the built-in device shielding, the intestines are essentially protected from the radiation. With external beam radiation, it’s more difficult to pinpoint the tumor’s exact location, and protect the intestines to this degree,” Fields said.
Current treatment protocols typically include a combination of chemotherapy and external beam radiation in the neoadjuvant (pre-operative) setting to shrink the tumor prior to surgery. The new approach with CivaSheet adds a strong “boost” of radiation to this technique, offering patients an opportunity for targeted, localized treatment.
CivaSheet has broad FDA clearance to include pancreatic cancer and many other malignancies. A multi-center, NIH sponsored research protocol aimed at testing the device’s safety and efficacy on controlling pancreatic cancer is awaiting approval at Massey and several other nationally recognized cancer centers in the U.S.