With this advantage, the hybrid imaging system demonstrates a further, cost effective tool for personalized treatment, enabling bedside usage during interventions. Its first application domain is the non-surgical sentinel lymph node imaging and biopsy in breast and melanoma patients. In the past month the hybrid SPECT/ultrasound imaging was evaluated at Klinikum rechts der Isar in Munich to image sentinel lymph nodes. The images are compared to scintigraphy, the current gold standard in sentinel lymph node imaging, with superior imaging results and thus indicated the advantage that it has with its ultrasound overlay to provide a direct mapping in the ultrasound image and show the highlighted lymph node in the anatomical context enabling a non-surgical removal of the sentinel lymph node.
The team of clinicians and researchers at Nuclear Medicine Department, Klinikum rechts der Isar, Munich evaluated the imaging accuracy the past months within 19 patients with a total of 21 sentinel lymph nodes. The sensitivity was found to be 100% compared to scintigraphy images in the detection of sentinel lymph nodes. “The data show the reliability of the method and the imaging and propose its further investigation for mapping of sentinel lymph nodes.” confirms Prof. Dr. Markus Schwaiger. “The SPECT/Ultrasound hybrid imaging demonstrates a further tool for personalized treatment, enabling bedside usage during interventions”. The imaging study will be completed before the end of the year with more than 50 patients and the final results will be presented during 2015.
The team of clinicians and researchers at Nuclear Medicine Department, Klinikum rechts der Isar, Munich evaluated the imaging accuracy the past months within 19 patients with a total of 21 sentinel lymph nodes. The sensitivity was found to be 100% compared to scintigraphy images in the detection of sentinel lymph nodes. “The data show the reliability of the method and the imaging and propose its further investigation for mapping of sentinel lymph nodes.” confirms Prof. Dr. Markus Schwaiger. “The SPECT/Ultrasound hybrid imaging demonstrates a further tool for personalized treatment, enabling bedside usage during interventions”. The imaging study will be completed before the end of the year with more than 50 patients and the final results will be presented during 2015.
The excellent results of the image validation led to a study demonstrating minimal invasive sentinel lymph node removal with a biopsy device. The procedure will be performed with an ultrasound guided biopsy procedure and spare the entire surgical excision of the lymph node, reducing the risk of complications in the axilla. “With our four year experience in intraoperative 3D imaging and navigation with SurgicEye’s technology and the promising results of the imaging evaluation we initiated a study to deliver a less invasive management of the axilla, avoiding the surgical removal and thus unnecessary complications” Dr. Stefan Paepke, Head of Senology at Women’s Health, Klinikum rechts der Isar, Munich. “It will be a great advantage for our patients. They will not only benefit from the less invasive procedure, but also from the integration of the sentinel lymph node staging during the diagnostic workup of the breast. This will enable us to have the complete picture of the tumor before treatment.” The study will be carried out during 2015 with Dr. Stefan Paepke from Klinikum rechts der Isar in Munich as principle investigator.
As an evolution of the intraoperative 3D imaging technology declipse®SPECT, the novel mobile and hybrid imaging technique is combining handheld, mobile SPECT imaging with ultrasound. It provides a registration free SPECT/ultrasound fusion i.e. there is no user interaction required to have the SPECT image information overlaid on the ultrasound image in real-time.
The declipse®SPECT System and the overlay in the ultrasound system are CE and FDA cleared and will be presented during the 100th RSNA Nov 30-Dec 04, 2014 in Chicago, USA.
About SurgicEye GmbH
SurgicEye GmbH is a pioneer in soft tissue imaging and navigated interventions. The declipse®SPECT from SurgicEye® is the world’s first CE and FDA certified product for intra-operative 3D imaging and navigation solution of radioactive labeled structures. This enables a less invasive approach for radio-guided surgery in e.g. breast, head & neck, cervix and prostate cancers and melanoma. Further this technique can be used in order radio-guided surgery procedures. With SentiGuide® the first hybrid SPECT/Ultrasound system was introduced for non-surgical sentinel lymph node biopsy. Ongoing clinical investigations in other tumor surgery domains promise a wide application domain and huge potential for quality assurance during interventional procedures.
For further information please visit www.surgiceye.com.
SurgicEye GmbH
Friedenst. 18A, 81671 Munich, Germany
info@surgiceye.com fon: +49 89 54 99 89 001
