Spots Global Cancer Trial Database for Evaluation of Sentinel Lymph Nodes in Head and Neck Squamous Cell Carcinoma
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Trial Identification
Brief Title: Evaluation of Sentinel Lymph Nodes in Head and Neck Squamous Cell Carcinoma
Official Title: A Ph 3, Prospective, Open-Label, Multicenter Study of Lymphoseek®-Identified Sentinel Lymph Nodes (SLNs) Relative to the Path Status of Non SLN in an Elective Neck Dissection in Cutaneous Head and Neck and Intraoral Squamous Cell Carcinoma
Study ID: NCT00911326
Interventions
Study Description
Brief 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama, Birmingham, Birminham, Alabama, United States
Moores UCSD Cancer Center, La Jolla, California, United States
San Diego VA Hospital, San Diego, California, United States
University of Miami, Sylvester Comprehensive Cancer Center, Miami, Florida, United States
University of Kansas Medical Center, Kansas City, Kansas, United States
University of Michigan Medical Center, Ann Arbor, Michigan, United States
University of Mississippi, Jackson, Mississippi, United States
University of Missouri-Ellis Fischel Cancer Center, Columbia, Missouri, United States
University of Nebraska, Omaha, Nebraska, United States
Duke University Medical Center, Durham, North Carolina, United States
The Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
Thomas Jefferson University, Philadelphia, Pennsylvania, United States
MD Anderson, Houston, Texas, United States
Contact Details
Name: Bonnie C Abbruzzese, MS RD
Affiliation: Navidea Biopharmaceuticals
Role: STUDY_DIRECTOR
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