Breast and Melanoma Trial With Lymphoseek to Identify Lymph Nodes
Public ClinicalTrials.gov record NCT01106040. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT01106040
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 163 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 2010 (Type not available)
- Primary completion
- Apr 2011 (Actual)
- Completion
- Apr 2011 (Actual)
- Last update posted
- Jun 17, 2013
2010 – 2011
United States locations
- U.S. sites
- 8
- U.S. states
- 4
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama, Birmingham | Birmingham | Alabama | 35294 | — |
| UCSD Moores Cancer Center | La Jolla | California | 92093 | — |
| Califonia Pacific Medical Center | San Francisco | California | 94115 | — |
| John Wayne Cancer Institute | Santa Monica | California | 90404 | — |
| H. Lee Moffitt Cancer Center | Tampa | Florida | 33612 | — |
| University Hospitals Cleveland | Cleveland | Ohio | 44106 | — |
| Breast Care Specialists | Columbus | Ohio | 43081 | — |
| The Ohio State University | Columbus | Ohio | 43210 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01106040, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 17, 2013 · Synced Oct 18, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01106040 live on ClinicalTrials.gov.