Ireland-based Navidea Biopharmaceuticals has started patient enrolment in a clinical trial comparing Lymphoseek (technetium Tc 99m tilmanocept) injection and vital blue dye (VBD) in children with melanoma, rhabdomyosarcoma, or other solid tumours.
The prospective trial is designed to evaluate how Lymphoseek compares with VBD in identifying lymph nodes, as well as assess safety and tolerability.
Enrolment is currently planned at about six sites across the US, with the first patient being enrolled by the Nationwide Children’s Hospital in Columbus.
Lymphoseek is developed to precisely identify lymph nodes that drain from a primary tumour, which have the highest probability of harbouring cancer, and is approved for adult use only.
Nationwide Children’s Hospital Division of Pediatric Surgery director of Surgical Oncology Jennifer Aldrink said: "We are pleased to participate in this important clinical study of Lymphoseek in the paediatric patient population where no lymph node mapping agents have yet been approved.
"Intraoperative Lymphatic Mapping (ILM) and Sentinel Lymph Node Biopsy (SLNB) are standards of care in adult and paediatric patients in several forms of cancer, and Lymphoseek is a new agent being used in many adult centres as an alternative to sulphur colloid formulation.
"Lymphoseek may have the potential to aid physicians in evaluating lymph nodes in children that are necessary for accurate disease staging and optimal post-surgical treatment."
The trial’s primary goals 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.
Navidea chief medical officer Dr Michael Tomblyn said: "This study will provide further data on the overall clinical value of Lymphoseek, which has already shown to be a highly effective immunodiagnostic tool in adult patients.
"Medical literature supports the importance of lymph node evaluations in paediatric patients with rhabdomyosarcoma and melanomas noting that lymph node metastases are highly associated with poorer survival.
"Until now, there have been few studies of ILM and SLNB in children. We look forward to the opportunity to evaluate Lymphoseek’s use in paediatric populations."
The trial will also measure other efficacy signals, and assess the identified lymph nodes.