Evaluation of Sentinel Lymph Nodes in Head and Neck Squamous Cell Carcinoma
Status:
Terminated
Trial end date:
2013-08-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to determine the false negative rate (FNR) associated with
Lymphoseek-identified sentinel lymph nodes (SLNs) relative to the pathological status of
non-sentinel lymph nodes in elective neck dissection (END) in head & neck squamous cell
carcinoma (HNSCC). NEO3-06 (this study) is a Phase 3 clinical trial designed to supplement
NEO3-05, a completed Phase 3 clinical trial conducted in patients with breast cancer or
melanoma. NEO3-05 was designed to establish Lymphoseek as an effective radio-diagnostic agent
to be used in the intraoperative localization of lymph tissue (nodes) in the lymphatic
pathway draining the primary site of a tumor.