99mTc-Tilmanocept for Sentinel Lymph Node Biopsy in Cervical Cancer Surgeries

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DESCRIPTION (provided by applicant): Navidea Biopharmaceuticals (Navidea) is seeking SBIR FastTrack grant support to investigate the clinical utility, safety, and efficacy of its new product, 99mTc-tilmanocept, to identify sentinel lymph nodes (SLNs) during surgeries to remove early stage cervical cancers with the intent of improving patient outcomes and reducing post-surgical morbidities in patients undergoing these operations. Cancer patients can frequently be cured of their illnesses by surgeries that remove their tumors. To be successful, these surgeries must remove all of a patient's cancer. Residual tumor tissue in patients after surgery can result in potentially life threatening disease recurrences. It is very common that the first places to which a cancer may spread (metastasize) beyond the primary tumor are to lymph nodes that are immediately downstream from the tumor in the lymphatic flow, the SLNs. Previously and/or currently, it is/was standard of care in cervical cancer surgeries to remove e20 lymph nodes and examine these lymph nodes for the presence of cancer. This surgical strategy presumably removes any lymph node metastases and provides important disease staging information that guides postsurgical treatment decisions. However, wholesale lymph node removal frequently causes patients to develop lymphedema, a serious post-surgical complication, among other morbidities. Alternatively, a surgeon can identify the SLNs. If the SLNs are free of cancer, it is very unlikely that cancer has spread to other lymph nodes further downstream in the lymphatic drainage pathways. Patients with cancer free correctly identified SLNs can be spared from extensive node removal, frequently avoiding serious post-surgical morbidities. A particular concern in using SLN mapping in cervical cancer patients is that because of the anatomical position of the cervix, lymphatic drainage proceeds bilaterally. In order to be effective, SLNs must be detected bilaterally in cervical cancer surgeries for SLN identification to be considered complete and adequate. Current competitors of 99mTc-tilmanocept cannot identify SLNs bilaterally in ~25% of cases. With the proposed study, Navidea is initiating efforts to evaluate 99mTc-tilmanocept's SLN identification performance in cervical cancer surgeries. Ultimately, the goal of this project is to amend the 99mTc-tilmanocept New Drug Application (NDA) to include an indication for lymphatic mapping in cervical cancer surgeries, thus permitting the benefits of 99mTc-tilmanocept to be extended to cervical cancer patients. The proposed study is designed as an open-label, within-patient study of 99mTc-tilmanocept and an alternative mapping agent (Lymphazurin(R)) for detection of nodes in patients with cervical cancer. The study will determine how well SLN identification with Lymphazurin and 99mTc-tilmanocept compare with each other. Additionally, the SLN pathology, the global gold standard for false negative rates, will be contrasted between agents and between the pathology of all nodes that may be removed during the procedure (non-SLNs). The study will also focus on the ability of 99mTc-tilmanocept to facilitate detection of SLNs bilaterally. The study will involve ~40 patients and last 1.5 yrs.