CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 163 enrolled
Drug / intervention
Lymphoseekdrug
Likely dose
Lymphoseek 1.0 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01106040
NCT01106040Phase 3Completed
CompareCT.gov

A Phase 3, Prospective, Open-Label, Multicenter Comparison Study of Lymphoseek® and Vital Blue Dye as Lymphoid Tissue Targeting Agents in Patients With Known Melanoma or Breast Cancer Who Are Undergoing Lymph Node Mapping

Navidea Biopharmaceuticals·interventional·Posted Apr 19, 2010·Updated Jun 17, 2013

In Brief

A Phase 3 clinical trial evaluating Lymphoseek for Breast Cancer and Melanoma. Completed, enrolled 163 participants across 8 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer, Melanoma
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 19, 2010
Enrollment StartJun 1, 2010
Primary CompletionApr 1, 2011
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 16.2 years ago

Interventions

Lymphoseekdrug

The total volume of Lymphoseek injection will be between 0.1 - 1.0 mL.