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NCT00671918 · ClinicalTrials.gov registry record · Phase 3

Trial of Lymphoseek in Intraoperative Localization of Lymph Nodes in Breast Cancer and Melanoma

A Phase 3 study, sponsored by Navidea Biopharmaceuticals.

Completed
Registry status
Phase 3
Development phase
186
Enrollment target

NCT00671918: Completed Phase 3 study, sponsored by Navidea Biopharmaceuticals.

NCT00671918 is a Phase 3 study that has completed, run by Navidea Biopharmaceuticals. The registered enrollment target is 186 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (76% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00671918, a Phase 3 study, has completed, sponsored by Navidea Biopharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
186 participants
Enrollment target

Study Summary

Data from this pivotal clinical trial will be used to support a marketing application (i.e., NDA) for Navidea's Lymphoseek for use in intraoperative localization of lymph tissue (nodes) in the lymphatic pathway draining the primary site of a tumor.

Primary Outcome

The proportion of lymph nodes detected intraoperatively by blue dye that were also detected by Lymphoseek.

Interventions

  • DRUG Lymphoseek

Trial Details

FieldValue
Enrollment Target 186 participants
Start Date 2008-04
Est. Completion 2009-07
Phase Phase 3
Navidea Biopharmaceuticals

15 total trials

What the finished NCT00671918 record still lists

NCT00671918 is an interventional study that assigns participants to a tested intervention. The registered 186 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 (76% lower).

The record links to 0 conditions, and to 1 intervention - of which Lymphoseek is the first listed.

NCT00671918 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00671918 about?

NCT00671918 is a clinical study titled "Trial of Lymphoseek in Intraoperative Localization of Lymph Nodes in Breast Cancer and Melanoma". Data from this pivotal clinical trial will be used to support a marketing application (i.e., NDA) for Navidea's Lymphoseek for use in intraoperative localization of lymph tissue (nodes) in the lymphatic pathway draining the primary site of a tumor.

What is the current status of trial NCT00671918?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 186 participants. The study started on 2008-04. Estimated completion is 2009-07.

What interventions are being tested in trial NCT00671918?

The interventions under investigation include: Lymphoseek (DRUG).

Who is sponsoring clinical trial NCT00671918?

This trial is sponsored by Navidea Biopharmaceuticals, which has 15 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00671918's enrollment target sits among peer trials

186 1412th of 2000 higher than 584 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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Source: ClinicalTrials.gov NCT00671918, the US trial registry maintained by the National Library of Medicine. NCT00671918 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.