For Healthcare Professionals
Clinical Data
Clinical
You're already utilizing the latest technologies available in radiation therapy to deliver precise, highly conformal radiation therapy. But until now, there has been no way to confirm accurate delivery of the prescribed treatment plan.
The multi-center clinical trial revealed deviations from planned dose occurred more often than expected. More importantly, without DVS® physicians are unable to identify those patients who received significant variations affecting cumulative dose that could have a profound impact on tumor control and surrounding normal tissue.
Clinical Trial DataDVS has been evaluated in a multi-center trial to evaluate the safety and use of DVS in patients with prostate and breast cancer requiring radiation therapy and to collect information regarding in vivo dose measurements using the device. The trial demonstrates DVS is safe for long-term implantation for the purpose of measuring radiation dose in breast and prostate cancer, is an effective tool for quantifying dose at depth and can be used as a guide, in conjunction with existing planning and deliver tools, for the application of radiotherapy on an individual patient basis. Additionally, dose data from DVS can be used collectively to evaluate adherence, on an institutional basis, to national dose protocols.
Refer to the DVS Instructions for Use for complete details about the clinical trial.
Clinical Trial DesignThirty-eight breast cancer patients and thirty-one prostate cancer patients were enrolled in the study. A total of 126 dosimeters were implanted in participating patients. Sixty-three patients completed therapy. A total of 3532 individual dose measurements were made during the study period.
Patients were implanted with one or two dosimeters. One dosimeter was implanted at the peripheral margin of the tumor (gross tumor volume, GTV) or in the tumor bed following removal. The second dosimeter was implanted in the clinical target volume (CTV), at least 1-2 cm from the GTV in the normal tissue. All dosimeters were to be implanted at least 3 cm from the skin surface and no more than 12cm deep from either the anterior or posterior skin surface. The dosimeters were secured using the polyester retention material provided. Medical imaging, where necessary, was used during the insertion. Surgeons documented adverse event and complications information.
CT scans in the treatment position were used to identify dosimeter migration. Daily pre-dose and post-dose dosimeter readings were taken for each fraction.
ResultsOf the 126 implant procedures performed on prostate and breast cancer subjects, thirteen surgical and non-surgical events were attributable to the device. All adverse events were graded as mild or moderate in toxicity and within expected results. Four incidents of device migration were reported.
In the 30 breast cancer patients completing radiation therapy, the incidence of deviations from planned dose at a level of 7% or higher was 21% and the incidence of deviations of 5% or higher was 40% (See Figure 1 below). Seventy-three percent of patients had at least one dosimeter that registered 5% or greater deviations at least 25% of the time and 30% of patients registered deviations 7% or greater 25% of the time.
The incidence of deviations from planned dose in the thirty prostate patients completing radiation therapy at a level of 7% or greater was 22% and the incidence of deviations >5% was 36% (See Figure 2 below). Sixty-six percent of patients had at least one dosimeter that registered 5% or greater variations at least 25% of the time during primary field treatment. Additionally, 31% of patients registered 7% or greater variations at least 25% of the time. During boost field treatment, 72% of patients had at least one dosimeter that registered deviations >5% at least 25% of the time and 56% of patients registered deviations >7% at least 25% of the time.
