Européenne
Prof Dr Martijn van Griensven is Full Professor of regenerative medicine and Chair of the Department Cell Biology-Inspired Tissue Engineering (cBITE) at the MERLN Institute for Technology-Inspired Regenerative Medicine at Maastricht University, Netherlands. Martijn studied in Leiden, Netherlands and subsequently obtained his PhD in Hannover, Germany. In 2002, he was appointed as Professor for experimental trauma surgery and became co-director of the LBI for Experimental and Clinical Traumatology in Vienna, Austria in 2005. He was appointed as Head of experimental trauma surgery at the Technical University of Munich, Germany in 2011. He is a visiting Professor at Universidad Peruane Cayetano Heredia in Lima, Peru and Professor at the UNESCO Chair for biomaterials at Universidad de la Habana, Cuba. Furthermore, he is an official Associate Researcher at the Musculoskeletal Gene Research Group at the Department of Rehabilitation, Mayo Clinic, USA. His research areas are related to engineering methods for the musculoskeletal system.
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Female subjects with a diagnosis of invasive breast cancer scheduled to have wide local excision (WLE) +/- sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND) will be screened and receive 18F-FDG plus LightPath® Image. Subjects will have standard of care WLE. Extra cavity shaving due to positive 18F-FDG LightPath® Images is at the discretion of the surgeon.
Subjects will receive an intravenous injection of up to 5 MBq/kg, to a maximum 300 MegaBecquerel (MBq) of 18F-FDG prior to surgery.
Following resection, the WLE specimen will be examined using the LightPath® Imaging System. If the surgeons detect a positive signal they may perform cavity shavings of the resection cavity area corresponding to the positive signal area (up to a maximum thickness of 10mm).
Axillary SLNB will be performed according to local practice. At sites where 99mTc is used: In the 18F-FDG + LightPath® a higher dose of up to 150 MBq technetium-99m (99mTc) nanocolloid is necessary to avoid 18F-FDG masking the signal from 99mTc. Blue dye will be used according to local practice at sites where it is considered standard of care.
Sentinel lymph nodes (SLNs) will be examined using the LightPath® Imaging System. Where clinically indicated, ALND will be performed as per standard of care. At the time this protocol was finalised, LightPath® data involved lymph nodes sufficient to support recommendations were not available. For this reason, LightPath® Image results will not be used to direct ALND.
All LightPath® Images will be performed between 60 and 180 minutes post injection of 18F-FDG.
The WLE specimen, cavity shavings (where performed) and SLNs (where performed) will then undergo standard of care histopathological analysis. Lymph nodes will also be examined according to standard of care histopathological analysis. The results of the histopathological analysis will then be correlated with the LightPath® Images.
All staff in the operating room will wear badge dosimeters. Staff handling surgical specimens in theatre will also wear ring dosimeters. Histopathology analyses should be delayed to allow for radioactive decay of tissue samples to suitably low levels.
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Subjects will be evaluated at screening and enrolment into the study. Data will be collected until the decision by the study site's MDT to recommend re-excision or mastectomy because of a positive margin on histopathological analysis (approx. 1-6 weeks post surgery)