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NCT01106040 · ClinicalTrials.gov registry record · Phase 3
Breast and Melanoma Trial With Lymphoseek to Identify Lymph Nodes
A Phase 3 study, sponsored by Navidea Biopharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 163
- Enrollment target
NCT01106040: Completed Phase 3 study, sponsored by Navidea Biopharmaceuticals.
NCT01106040 is a Phase 3 study that has completed, run by Navidea Biopharmaceuticals. The registered enrollment target is 163 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01106040, a Phase 3 study, has completed, sponsored by Navidea Biopharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 163 participants
- Enrollment target
Study Summary
Data from this pivotal clinical trial will be used to support a marketing application (i.e., NDA) of Navidea's Lymphoseek for use in anatomical delineation of lymphoid tissue (nodes) in the lymphatic pathway draining the primary site of a tumor. Multicenter, open-label, within-patient comparative study of Lymphoseek and vital blue dye in the detection of excised lymph nodes in patients with known melanoma and breast cancer. All patients will receive a single dose of 50 µg Lymphoseek radiolabeled with 0.5 or 2.0 mCi Tc 99m and vital blue dye.
Primary Outcome
The proportion of lymph nodes detected intraoperatively by blue dye that were also detected by Lymphoseek.
Interventions
- DRUG Lymphoseek
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 163 participants |
| Start Date | 2010-06 |
| Est. Completion | 2011-04 |
| Phase | Phase 3 |
What the finished NCT01106040 record still lists
NCT01106040 is an interventional study that assigns participants to a tested intervention. The registered 163 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 (79% lower).
The record links to 0 conditions, and to 1 intervention - of which Lymphoseek is the first listed.
NCT01106040 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01106040 about?
NCT01106040 is a clinical study titled "Breast and Melanoma Trial With Lymphoseek to Identify Lymph Nodes". Data from this pivotal clinical trial will be used to support a marketing application (i.e., NDA) of Navidea's Lymphoseek for use in anatomical delineation of lymphoid tissue (nodes) in the lymphatic pathway draining the primary site of a tumor. Multicenter, open-label, within-patient comparative s...
What is the current status of trial NCT01106040?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 163 participants. The study started on 2010-06. Estimated completion is 2011-04.
What interventions are being tested in trial NCT01106040?
The interventions under investigation include: Lymphoseek (DRUG).
Who is sponsoring clinical trial NCT01106040?
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 NCT01106040's enrollment target sits among peer trials
163 1471st of 2000 higher than 527 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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