Lymphoseek is a radioactive diagnostic agent.
Technetium Tc 99m tilmanocept may be used to enhance identification of lymph nodes in pediatric and adult patients with certain tumors.
The radiopharmaceutical diagnostic agent technetium Tc 99m tilmanocept was granted approval by the FDA for the identification of lymph nodes in pediatric patients with melanoma, rhabdomyosarcoma (RMS), and other solid tumors.
The study of pediatric patients with melanoma, rhabdomyosarcoma, and other solid tumors, lymphatic mapping was performed 15 minutes following technetium Tc 99m tilmanocept injection.
The overall rate of lymph node detection, defined as at least 1 lymph node per patients, was 96%.
The average number of lymph nodes detected per patient was 3.
All nodes identified using blue dye were also identified with technetium Tc 99m tilmanocept.
The agent is also approved for guiding sentinel lymph node biopsy in patients with clinically node negative squamous cell carcinoma of the oral cavity, breast cancer or melanoma.
A radioactive diagnostic imaging agent (technetium 99m tilmanocept) injection to guide sentinel lymph node biopsy in patients with cancer of the head and neck.
Lymphoseek as a lymphatic mapping agent for solid tumors, where it is a component of the intraoperative procedure in melanoma, breast cancer, and oral cavity squamous cell carcinoma.
Sentinel lymph node biopsy guided by this imaging agent accurately determines if disease had spread through the lymphatic system.
The agent enhances lymphatic mapping and sentinel lymph node biopsy in adult and pediatric patients 1 month or older with melanoma, rhabdomyosarcoma and other solid tumors.
Allows more accurately stage the spread of disease using lymphatic mapping..
In a trial, lymph node dissection revealed that 39 patients in the trial had pathologically positive lymph nodes and the isotope correctly identified 38 of the 39 patients with positive lymph notes, representing a false negative rate of 2.56%.
Among the 39 patients with positive nodes, standard multiple level nodal dissection led to the removal of an average of 38 lymph nodes per patient.
Utilizing of Lymphoseek in the trial indicated the removal of only 4 lymph nodes on average per patient, a significant reduction in potential morbidity for patients.
Based on this data approximately 75% of patients with stage I and II oral cavity head and neck cancer may be overtreated if they are subjected to elective neck dissection, which involves surgical removal of a regional lymph node chain involving 30 to 45 lymph nodes,
The trial determined a sensitivity of 97.6%, and negative predictive value of 97.8%, with an overall accuracy of 98.8% relative to the pathology status of non-sentinel lymph nodes.
The most common side effects with its use are pain and/or injection site irritation in less than 1% of cases.
Less than 1% of patients experiencing injection site reaction and/or pain on clinical trials.
No serious adverse effects of therapy have been reported.