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Evaluation of Sentinel Lymph Nodes in Head and Neck Squamous Cell Carcinoma

NCT00911326 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2014-08-08

Study results available
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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.

Conditions

  • Head and Neck Squamous Cell Carcinoma (HNSCC)

Interventions

DRUG

Lymphoseek

Single injection of 50 micrograms Lymphoseek radiolabeled with either 0.5 mCi (for same day surgery) or 2.0 mCi (for next day surgery) of Tc 99m

Sponsors & Collaborators

  • Navidea Biopharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Bonnie C Abbruzzese, MS RD · Navidea Biopharmaceuticals

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2013-08-31
Completion
2013-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00911326 on ClinicalTrials.gov