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Many women diagnosed with breast cancer undergo radiation as part of their treatment. The benefit of radiation therapy in helping to stop cancer cells from growing and dividing usually outweighs the risk for most breast cancer patients. However, because the treatment involves the administration of radiation, radiologists want to ensure that that the dosage is correct and targeted to maximize the effect on cancerous tissue while minimizing the effect on healthy tissue. The dose verification system (DVS), which is manufactured by Sicel Technologies, has been approved by the U.S. Food and Drug Administration (FDA) for radiation treatment of breast and prostate cancer in 2006. "Increasingly, we are utilizing radiation therapy protocols designed to deliver higher doses of radiation to smaller targeted areas. These protocols enable us to effectively kill cancerous cells while minimizing damage to surrounding healthy tissue that may result in unwanted side effects," says Catherine Lee M.D., Rex Cancer Center Raleigh, NC, in a 2008 Sicel Technologies news release. "But they also require a high degree of accuracy and precision to be successful. DVS confirms that the radiation we prescribe for our patient is getting to the intended target, and alerts us to variations during the course of treatment when there is an opportunity to evaluate and correct, if necessary, the cause of the variations." DVS helps radiologists determine the amount of radiation a patient receives is within the prescribed range each time radiation treatments are administered. To do so, the radiologist can use the system measures the amount of radiation that is delivered to the tumor tissue, tumor bed, or healthy tissue. DVS differs from normal radiation therapy in that the physician must implant DVS radiation dosimeters near the tumor or tumor bed and/or surrounding normal tissue during a minimally invasive procedure. Most patients receive one or two dosimeters. Once implanted, wireless technology transmits the information to a hand-held monitor and radiation absorption rates are read during daily treatments, enabling radiologists to verify that the dose received by the patient is within the prescribed range. The dosimeter does not produce radiation itself. The DVS implantable dosimeter is 0.8 inches (20mm) long and 0.08 inches (2.1mm) in diameter. During radiation treatment, each dosimeter transmits the amount of radiation that is received at its location. The dosimeter near the tumor should receive the highest dose, while the other receives a lower dose. After radiation treatment sessions are completed, the dosimeters will remain inside the patient without an effect on a patient's daily routine. In January 2008, the U.S. Centers for Medicare and Medicaid created a new HCPCS code (Healthcare Common Procedure Coding System) for the DVS. The code will cover the cost for the Dose Verification System (DVS). The code, which reimburses radiation therapy centers for the medical device when implanted in any body site, makes DVS more accessible to patients undergoing radiation treatment for breast and prostate cancer because private insurers will cover the cost for the device. The cost for the device is also adequately covered by the new code for Medicare patients treated in freestanding centers. Separate codes are available to cover the cost associated with implanting the device. The patient's physician will determine whether she is a candidate for DVS. Some patients have experienced discomfort after the implantation of the DVS dosimeters; however, according to Sicel Technologies, no adverse long-term effects have been reported.
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