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|Navidea to Collaborate with Maimonides Medical Center on Clinical Trial Utilizing Lymphoseek® for Lymphatic Mapping in Colorectal Cancer|
‒ Study will evaluate use of Lymphoseek to pinpoint lymph nodes most likely to contain cancer ‒
"While colorectal surgeons have a strong interest in being able to more accurately pinpoint lymph nodes most likely to contain cancer from among the full draining bed of nodes removed during colorectal cancer resection, the field has been awaiting the advent of a suitable lymphatic mapping agent,” commented Dr. Sherwinter. “Although efforts are growing in the use of lymph node mapping in colorectal cancer, the poor sensitivity of current agents and techniques has hindered progress in the field. Due to its receptor-targeting properties and strong performance in other malignancies such as breast and melanoma, Lymphoseek holds promise to open new opportunities in the field of lymphatic mapping in colorectal cancer."
Currently, the approach to lymph node assessment in colorectal cancer is to remove the entire lymph node basin during colon resection surgery, resulting in a large number of lymph nodes for pathology analysis. Interest in lymphatic mapping in colorectal cancer is growing however broad application is impeded by limitations in existing technology which have been associated with high false negative rates.3 With results from Phase III studies demonstrating its rapid injection site clearance and retained localization to key predictive lymph nodes, Lymphoseek has performance advantages that may be well suited to lymphatic mapping in settings such as colorectal cancer in an effort to reduce false negative rates and morbidity, and provide improved diagnostic accuracy.
"This study represents an important step forward in advancing
Lymphoseek’s medical and market potential in additional cancers where
lymphatic mapping may be very useful but in which effective technologies
haven't been developed,” said
Lymphoseek® (technetium Tc 99m tilmanocept) Injection is a novel, receptor-targeted, small-molecule, investigational radiopharmaceutical used in lymphatic mapping procedures that are performed to help stage cancers such as breast cancer and melanoma. Lymphoseek is designed to identify the lymph nodes that drain from a primary tumor, which have the highest probability of harboring cancer.
Lymphatic mapping is a procedure in which lymph nodes that may contain
tumor metastases are identified and biopsied to determine if cancer has
spread beyond the primary tumor. Accurate staging of cancer is critical,
as it guides therapy decisions and determines patient prognosis and risk
of recurrence. According to the
About Lymphatic Mapping
Lymphatic mapping is a procedure designed to guide lymph node dissection and biopsy procedures. It consists of Intraoperative Lymphatic Mapping (ILM) often accompanied by lymphoscintigraphy. Lymphoscintigraphy is an imaging procedure routinely performed pre-operatively to provide guidance on the location of lymph nodes to be biopsied. ILM is a surgical procedure in which lymph nodes draining the area around a tumor are identified and biopsied to determine if cancer has spread to the lymph nodes. These nodes, commonly referred to as “Sentinel Lymph Nodes,” are removed and analyzed for the presence of malignant cells. Lymphatic Mapping provides an accurate staging procedure that can help ensure optimal surgical and therapeutic choices, including the avoidance of the morbidity of a complete lymph node dissection for patients in whom the Sentinel Lymph Nodes were found to be free of cancer.
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1 Cancer Statistics, 2013. CA Cancer J Clin, 2013;63:11–30
2 Ferlay J et al; "GLOBOCAN 2008: Estimated
Incidence, and Mortality and Prevalence Worldwide in 2008." IARC
CancerBase No. 10;
3 Tiffet O et al; “Combining radioisotopic and blue-dye technique does not improve the false-negative rate in sentinel lymph node mapping for colorectal cancer.” Dis Colon Rectum. 2007 Jul;50(7):962-70.
Navidea Biopharmaceuticals, Inc.