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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 is a Phase 3 study that was terminated before completion, run by Navidea Biopharmaceuticals. The registered enrollment target is 101 participants.
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.
Interventions
- DRUG Lymphoseek
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 101 participants |
| Start Date | 2009-05 |
| Est. Completion | 2013-08 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00911326
The ClinicalTrials.gov registry entry for NCT00911326 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 101 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Navidea Biopharmaceuticals, which has 15 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Lymphoseek is the first listed.
NCT00911326 reports 0 study locations.
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.
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