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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 is a Phase 3 study that has completed, run by Navidea Biopharmaceuticals. The registered enrollment target is 163 participants.
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.
Interventions
- DRUG Lymphoseek
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 163 participants |
| Start Date | 2010-06 |
| Est. Completion | 2011-04 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01106040
The ClinicalTrials.gov registry entry for NCT01106040 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 163 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.
NCT01106040 reports 0 study locations.
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.
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