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Data from this pivotal clinical trial will be used to support a marketing application (i.e., NDA) of Neoprobe's Lymphoseek for use in anatomical delineation of lymphoid tissue (nodes) in the lymphatic pathway draining the primary site of a tumor.
Multicenter, open-label, within-patient comparative study of Lymphoseek and vital blue dye in the detection of excised lymph nodes in patients with known melanoma and breast cancer. All patients will receive a single dose of 50 µg Lymphoseek radiolabeled with 0.5 or 1.0 mCi Tc 99m and vital blue dye.
In patients with primary melanoma and breast cancer, lymph node status is often a strong predictor of outcome and influences the course of treatment a patient may follow after surgery. In an effort to reduce the morbidity and costs of detection of lymph node metastases, surgical oncologists have developed a method by which the sentinel lymph node (SLN; the first node in a draining basin) is identified intraoperatively and removed. This technique, called sentinel node biopsy, has extremely high negative predictive values for melanoma  metastases and breast cancer  metastases. The two largest trials for melanoma, Morton, et al (2005)  and Rossi, et al (2006) , reported false negative rates of 6.3% and 14.7%, respectively. Morton, et al (2006) , in perhaps the most mature trial reported to date, showed a false negative rate of 3.4%. There is growing evidence that sentinel node biopsy will have a significant impact on the management of melanoma. Sentinel node biopsy also has extremely high negative predictive values for breast cancer metastases ; the false-negative rates range from 0% to 9% [5-8]. There is growing evidence that sentinel node biopsy will have a significant impact on the management of breast cancer [5,9-11]. Although the survival and local recurrence studies have yet to be completed, the technique has emerged into common practice.
Intraoperative lymphatic mapping (ILM) with a radiopharmaceutical is a nuclear medicine examination which identifies for the surgeon the first lymph node to receive lymphatic flow from the primary tumor site. This node is removed and analyzed for the presence of malignant cells. By locating the lymph node prior to surgery, a small incision can be used to remove the node and a smaller dissection can be employed. The high negative predictive value of the technique seems to provide an accurate staging procedure and may spare patients who are lymph node negative the morbidity of a complete lymph node dissection [1,2]. Consequently, staging of melanoma by lymph node mapping and biopsy may be equivalent to regional node dissection without the attendant post surgical morbidity.
An ideal lymph node imaging agent would exhibit rapid clearance from the injection site, rapid uptake and high retention within the first draining lymph node, and low uptake by the remaining lymph nodes. The ideal agent would also have low radiation absorption; high biological safety; convenient, rapid, and stable technetium-99m labeling; and biochemical purity.
Lymphoseek (Technetium Tc 99m diethylenetriaminepentaacetic acid mannosyl dextran, [Tc 99m] DTPA Mannosyl Dextran) is a radiotracer that accumulates in lymphatic tissue by binding to a mannose binding protein that resides on the surface of dendritic cells and macrophages. Lymphoseek is a macromolecule consisting of multiple units of DTPA and mannose, each synthetically attached to a 10 kilodalton dextran backbone. The mannose acts as a substrate for the receptor, and the DTPA serves as a chelating agent for labeling with Tc 99m.
Lymphoseek has a diameter of about 5 nm, which is substantially smaller than current agents used for targeting lymphoid tissue. Lymphoseek's small diameter permits enhanced diffusion into lymph nodes and blood capillaries, resulting in a rapid injection site clearance. Upon entry into the blood, the agent binds to receptors in the liver or is filtered by the kidney and accumulates in the urinary bladder
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
UCSD Moores Cancer Center
Published on BioPortfolio: 2014-08-27T03:14:32-0400
Data from this pivotal clinical trial will be used to support a marketing application (i.e., NDA) for Neoprobe's Lymphoseek for use in intraoperative localization of lymph tissue (nodes) i...
To compare the kinetics and efficacy of two functionally different diagnostic agents, Lymphoseek (CD206 receptor targeted) and 99mTc-SC (Sulfur Colloid non-specific mapping agent) in intra...
Part of standard treatment for endometrial cancer is to remove one or more groups of lymph nodes (lymph node dissection). Lymph nodes are small, bean-shaped organs located within the body ...
The purpose of this study is to determine the false negative rate (FNR) associated with Lymphoseek-identified sentinel lymph nodes (SLNs) relative to the pathological status of non-sentine...
Prospective, open-label, within-subject, multi-center pilot study of Lymphoseek in the detection of lymph nodes in subjects with known squamous cell carcinoma of the anus.
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Early breast cancer follow-up guidelines for patients who underwent surgery suggest a regular and accurate clinical examination of the breast area, for an early identification of cutaneous or subcutan...
Abnormal accumulation of lymph in the arm, shoulder and breast area associated with surgical or radiation breast cancer treatments (e.g., MASTECTOMY).
Metastatic breast cancer characterized by EDEMA and ERYTHEMA of the affected breast due to LYMPHATIC METASTASIS and eventual obstruction of LYMPHATIC VESSELS by the cancer cells.
A infiltrating (invasive) breast cancer, relatively uncommon, accounting for only 5%-10% of breast tumors in most series. It is often an area of ill-defined thickening in the breast, in contrast to the dominant lump characteristic of ductal carcinoma. It is typically composed of small cells in a linear arrangement with a tendency to grow around ducts and lobules. There is likelihood of axillary nodal involvement with metastasis to meningeal and serosal surfaces. (DeVita Jr et al., Cancer: Principles & Practice of Oncology, 3d ed, p1205)
A deoxycytidine derivative and fluorouracil PRODRUG that is used as an ANTINEOPLASTIC ANTIMETABOLITE in the treatment of COLON CANCER; BREAST CANCER and GASTRIC CANCER.
Carbohydrate antigen elevated in patients with tumors of the breast, ovary, lung, and prostate as well as other disorders. The mucin is expressed normally by most glandular epithelia but shows particularly increased expression in the breast at lactation and in malignancy. It is thus an established serum marker for breast cancer.
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...
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