Navidea Biopharmaceuticals Inc. announced that the first pediatric patient was enrolled in a clinical study comparing Lymphoseek (technetium Tc 99m tilmanocept) injection and vital blue dye (VBD) in a pediatric population of patients with melanoma, rhabdomyosarcoma, or other solid tumors. The study is designed to investigate how Lymphoseek compares with VBD in identifying lymph nodes as well as evaluate safety and tolerability in the pediatric population. Lymphoseek is designed for the precise identification of lymph nodes that drain from a primary tumor, which have the high probability of harboring cancer and is approved for adult use only.

Enrollment is currently planned at approximately six sites throughout the U.S. The first patient has been enrolled by the Nationwide Children's Hospital in Columbus, OH. This study (NAV3-18) is a prospective, open-label, multicenter study comparing Lymphoseek and VBD as lymphoid tissue targeting agents in pediatric patients with melanoma, rhabdomyosarcoma, or other solid tumors who are undergoing lymph node mapping. Primary goals of this study are to evaluate safety and tolerability of Lymphoseek in this subject population and determine the concordance of in vivo detection rates of Lymphoseek and of VBD in tissue excised and histologically confirmed as lymph nodes.

In addition, the study will measure other efficacy signals including assessment of the identified lymph node(s) to confirm: the presence/absence of tumor metastases; agent localization per tumor type; degree of localization (nodes per subject both intraoperatively and with preoperative SPECT/CT); reverse concordance parameters; change of subject stage based on histopathology and descriptive assessment on change in treatment plan; number of lymph nodes detected with Lymphoseek intraoperatively compared with preoperative SPECT/CT imaging.