Date: 2015-08-20
Type of information: Publication of results in a medical journal
phase:
Announcement: publication of results in the Annals of Surgical Oncology
Company: Navidea Biopharmaceuticals (USA - OH)
Product: Lymphoseek® (technetium Tc 99m tilmanocept)
Action
mechanism: radiopharmaceutical. Lymphoseek® (technetium Tc 99m tilmanocept) Injection is a novel, receptor-targeted, small-molecule radiopharmaceutical used in lymphatic mapping procedures that are performed to help stage 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, in patients with breast cancer or melanoma.
Disease: breast cancer
Therapeutic area: Cancer - Oncology
Country:
Trial details:
Latest
news: * On August 20, 2015, Navidea Biopharmaceuticals announced publication of the results from an investigator-initiated, comparative study of Lymphoseek® (technetium Tc 99m tilmanocept) injection versus filtered Tc-99m Sulfur Colloid (fTcSC) measuring injection site pain in patients with breast cancer undergoing lymphoscintigraphy. The paper titled, \"Comparison of Post-injection Site Pain Between Technetium Sulfur Colloid and Technetium Tilmanocept in Breast Cancer Patients Undergoing Sentinel Lymph Node Biopsy,\" was published online in the Annals of Surgical Oncology [DOI - 10.1245/s10434-015-4802-y] and indicated, with patient-reported data, a statistically significant reduction in the level of post-injection associated pain using Lymphoseek compared with use of an fTcSC tracer. The publication included results of the randomized, double-blind clinical trial comparing post-injection site pain using fTcSC versus Lymphoseek in 52 [(27) fTcSC and (25) Lymphoseek] breast cancer patients undergoing lymphoscintigraphy. Pain was evaluated with a visual analogue scale and short form McGill Pain Questionnaire at 1, 2, 3, 4, 5, 15 and 30 minutes post-injection. Analysis of the data indicated baseline pain scores were similar between groups. At one minute post-injection, patients receiving fTcSC experienced a mean change in pain of 16.8mm (standard deviation (SD) 19.5) compared to 0.2mm (SD 7.3) in the Lymphoseek group (p =0.0002). Overall, patients receiving Lymphoseek experienced statistically significant less change in pain scores compared to patients receiving fTcSC at 1-3 minutes post-injection.
