Evaluation of Sentinel Lymph Nodes in Head and Neck Squamous Cell Carcinoma
Public ClinicalTrials.gov record NCT00911326. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00911326
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 101 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 2009 (Type not available)
- Primary completion
- Aug 2013 (Actual)
- Completion
- Aug 2013 (Actual)
- Last update posted
- Aug 8, 2014
2009 – 2013
United States locations
- U.S. sites
- 13
- U.S. states
- 12
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama, Birmingham | Birminham | Alabama | 35294 | — |
| Moores UCSD Cancer Center | La Jolla | California | 92093 | — |
| San Diego VA Hospital | San Diego | California | 92161 | — |
| University of Miami, Sylvester Comprehensive Cancer Center | Miami | Florida | 33136 | — |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | — |
| University of Michigan Medical Center | Ann Arbor | Michigan | 48109 | — |
| University of Mississippi | Jackson | Mississippi | 39216 | — |
| University of Missouri-Ellis Fischel Cancer Center | Columbia | Missouri | 65203 | — |
| University of Nebraska | Omaha | Nebraska | 68198 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| The Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | — |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | — |
| MD Anderson | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00911326, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 8, 2014 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00911326 live on ClinicalTrials.gov.