From radical to minimal-invasive – first clinical results of a method for non-surgical sentinel lymph node biopsy

From radical to minimal-invasive – first clinical results of a method for non-surgical sentinel lymph node biopsy
11th March 2015 admin

Promising results of the first non-surgical sentinel lymph node biopsies with SentiGuide are a further step towards a new standard for minimal invasive assessment of the lymphatic involvement in breast cancer. By overlaying mobile SPECT images onto a real-time ultrasound image, the technique is capable of extending the indication of needle biopsies in the axilla from suspicious lymph nodes to the sentinel lymph node. 

Next week during the 14th St Gallen Breast Cancer Conference in Vienna, Austria March 18-21 , the initial results of 10 patients will be presented by Dr. Stefan Paepke, senior assistant medical director of senology at the interdisciplinary breast center at Klinikum rechts der Isar, Munich, Germany. He is the principle investigator of the MinimalSNB study that is aimed to prove non-inferiority of the non-surgical approach. Together with an integrated ultrasound imaging system for the anatomical identification of the lymph node and an advanced needle biopsy solution that is capable of extracting a relevant sample size from the lymph node the SentiGuide imaging is the yet missing link to perform the sentinel lymph node biopsy as a non-surgical procedure.

Up to now more than 50 non-surgical biopsies of sentinel lymph nodes were performed without any complications and compared to its surgical counterpart that was done in parallel. “The results encourage us to continue towards making this method the least invasive one for a safe and reliable assessment of the lymph node involvement in our breast cancer treatment routine” concludes Dr. Paepke in the intermediate analysis of the data. “By the end of the year we will have the data ready to propose this as the new standard for axilla workup in our breast centers.”

SentiGuide replaces surgery by biopsy
Image 1: the surgical process of extraction of a sentinel lymph node is replaced by a fused SPECT/Ultrasound guided needle biopsy.

SentiGuide process
Image 2: SentiGuide is composed of freehand declipse®SPECT imaging, an integrated ultrasound system and image fusion as well as an advanced needle biopsy system.

SentiGuide biopsy
Image 3: SPECT/Ultrasound guided needle biopsy of the sentinel lymph node.


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
SurgicEye GmbH
Friedenst. 18A, 81671 Munich, Germany fon: +49 89 54 99 89 001