De Kruijf W.J.M.,Institute Verbeeten |
Verstraete J.,University Hospitals Leuven |
Neustadter D.,Navotek Medical Ltd |
Corn B.W.,Tel Aviv Medical Center |
And 9 more authors.
International Journal of Radiation Oncology Biology Physics | Year: 2013
Purpose: To evaluate the performance and safety of a radiation therapy positioning system (RealEye) based on tracking a radioactive marker (Tracer) implanted in patients with localized prostate cancer. Methods and Materials: We performed a single-arm multi-institutional trial in 20 patients. The iridium-192 (192Ir)-containing Tracer was implanted in the patient together with 4 standard gold seed fiducials. Patient prostate-related symptoms were evaluated with the International Prostate Symptom Score (IPSS) questionnaire. Computed tomography (CT) was performed for treatment planning, during treatment, and after treatment to evaluate the migration stability of the Tracer. At 5 treatment sessions, cone beam CT was performed to test the positioning accuracy of the RealEye. Results: The Tracer was successfully implanted in all patients. No device or procedure-related adverse events occurred. Changes in IPSS scores were limited. The difference between the mean change in Tracer-fiducial distance and the mean change in fiducial-fiducial distance was -0.39 mm (95% confidence interval [CI] upper boundary, -0.22 mm). The adjusted mean difference between Tracer position according to RealEye and the Tracer position on the CBCT for all patients was 1.34 mm (95% CI upper boundary, 1.41 mm). Conclusions: Implantation of the Tracer is feasible and safe. Migration stability of the Tracer is good. Prostate patients can be positioned and monitored accurately by using RealEye. © 2013 Elsevier Inc. All rights reserved.
Navotek Medical Ltd. | Date: 2008-07-11
Fiducial marker for medical applications, namely, a radioactive marker for use in marking tissues undergoing radiotherapy.
Navotek Medical Ltd. | Date: 2008-12-16
System for tracking the position of a tumor of a patient, comprising markers, sensors, computer software for tracking the markers attached to the tumors or to the tissue adjacent to the tumor, and data processors for use in radiotherapy applications.
Navotek Medical Ltd. | Date: 2007-12-04
Neustadter D.,Navotek Medical Ltd |
Barnea G.,Scientific Consultancy |
Stokar S.,Navotek Medical Ltd |
Corn B.,Tel Aviv Medical Center
Medical Physics | Year: 2010
Purpose: A fiducial tracking system based on a novel radioactive tracking technology is being developed for real-time target tracking in radiation therapy. In this study, the authors calculate the radiation dose to the patient, the spouse/caretaker, and the medical staff that would result from a 100 μCi Ir192 radioactive fiducial marker permanently implanted in the prostate of a radiation therapy patient. Methods: Local tissue dose was calculated by Monte Carlo simulation. The patient's whole body effective dose equivalent was calculated by summing the doses to the sensitive organs. Exposure of the spouse/caretaker was calculated from the NRC guidelines. Exposure of the medical staff was based on estimates of proximity to and time spent with the patient. Results: The local dose is below 40 Gy at 5 mm from the marker and below 10 Gy at 10 mm from the marker. The whole body effective dose equivalent to the patient is 64 mSv. The dose to the spouse/caretaker is 0.25 mSv. The annual exposures of the medical staff are 0.2 mSv for a doctor performing implantations and 0.34 mSv for a radiation therapist positioning patients for therapy. Conclusions: The local dose is not expected to have any clinically significant effect on the surrounding tissue which is irradiated during therapy. The dose to the patient is small in comparison to the whole body dose received from the therapy itself. The exposure of all other people is well below the recommended limits. The authors conclude that there is no radiation exposure related contraindication for use of this technology in the radiation treatment of prostate cancer. © 2010 American Association of Physicists in Medicine.