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NCT00911326 · ClinicalTrials.gov registry record · Phase 3
Evaluation of Sentinel Lymph Nodes in Head and Neck Squamous Cell Carcinoma
A Phase 3 study, sponsored by Navidea Biopharmaceuticals.
- Terminated
- Registry status
- Phase 3
- Development phase
- 101
- Enrollment target
NCT00911326: Clinical Trial Phase 3 study, sponsored by Navidea Biopharmaceuticals.
NCT00911326 is a Phase 3 study that was terminated before completion, run by Navidea Biopharmaceuticals. The registered enrollment target is 101 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00911326, a Phase 3 study, was terminated before completion, sponsored by Navidea Biopharmaceuticals.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 101 participants
- Enrollment target
Study 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.
Primary Outcome
The FNR is calculated as a percentage from the ratio of false negatives to the sum of true positives plus false negatives. The FNR point estimate was the observed rate and was made on a per-patient basis relative to patients with pathology-positive nodes.
Interventions
- DRUG Lymphoseek
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 101 participants |
| Start Date | 2009-05 |
| Est. Completion | 2013-08 |
| Phase | Phase 3 |
Why NCT00911326 stopped before completion
NCT00911326 is an interventional study that assigns participants to a tested intervention. The registered 101 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 1 intervention - of which Lymphoseek is the first listed.
NCT00911326 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00911326 about?
NCT00911326 is a clinical study titled "Evaluation of Sentinel Lymph Nodes in Head and Neck Squamous Cell Carcinoma". 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 s...
What is the current status of trial NCT00911326?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 101 participants. The study started on 2009-05. Estimated completion is 2013-08.
What interventions are being tested in trial NCT00911326?
The interventions under investigation include: Lymphoseek (DRUG).
Who is sponsoring clinical trial NCT00911326?
This trial is sponsored by Navidea Biopharmaceuticals, which has 15 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00911326's enrollment target sits among peer trials
101 1680th of 2000 higher than 320 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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