Sentinel lymph node accumulation of Lymphoseek and Tc-99m-sulfur colloid using a 2-day protocol

Lymphoseek is a receptor-binding radiopharmaceutical specifically designed for sentinel lymph node (SLN) mapping. We conducted a clinical trial which measured the injection site clearance and sentinel lymph node accumulation after a single intradermal injection of Lymphoseek or unfiltered [Tc-99m]sulfur colloid (TcSC) using a 2-day protocol for SLN mapping of breast cancer. Eleven patients with breast cancer participated in this study. Five patients received an intradermal administration of 1.0 nmol of Tc-99m-labeled Lymphoseek; SLN mapping was performed on four subjects within 19 to 27 h. Six subjects received an intradermal administration of TcSC; SLN mapping was performed on five subjects within 18 to 26 h. Lymphoseek exhibited a significantly (P<001) faster injection site clearance than TcSC. The mean Lymphoseek clearance half-time was 2.18 +/- 1.09 h compared to 57.4 +/- 92.8 h for TcSC. The mean sentinel lymph node uptake of Lymphoseek (1.5 +/- 1.7%) and TcSC (3.5 +/- 3.1%) was statistically equivalent (P=.213). When an intradermal injection is employed, Lymphoseek demonstrated faster injection site clearance than unfiltered [Tc-99m]sulfur colloid and persistent SLN accumulation for at least 24 h. (C) 2009 Elsevier Inc. All rights reserved.