SentiMag® Intraoperative Comparison in Breast Cancer
Public ClinicalTrials.gov record NCT02336737. 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 Pivotal, Prospective, Open-Label, Multicenter Paired Comparison Study Of SentiMag/SiennaXP And The Standard Of Care In Patients With Breast Cancer Who Are Undergoing Lymph Node Mapping As Part Of A Sentinel Node Biopsy Procedure
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this pivotal study is to provide prospective evidence that the SentiMag®/SiennaXP® is safe and non-inferior to the current standard of care for lymph node localization in patients with breast cancer as part of a sentinel lymph node biopsy (SLNB) procedure and to summarize measures of product safety and performance.
Study identification
- NCT ID
- NCT02336737
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 160 participants
Conditions and interventions
Conditions
Interventions
- SiennaXP Device
- Technetium Tc99m Sulfur Colloid Drug
- Isosulfan blue dye Drug
Device · Drug
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
- Jan 2015 (Type not available)
- Primary completion
- Dec 2015 (Actual)
- Completion
- Dec 2015 (Actual)
- Last update posted
- Nov 23, 2020
2015
United States locations
- U.S. sites
- 6
- U.S. states
- 3
- U.S. cities
- 6
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California San Diego Moores Cancer Center | La Jolla | California | 92093-0698 | — |
| University of California Davis Comprehensive Cancer Center | Sacramento | California | 95817 | — |
| UCSF Carol Franc Buck Breast Care Center | San Francisco | California | 94115 | — |
| Coordinated Health Breast Care Specialists | Allentown | Pennsylvania | 18104 | — |
| Dallas Surgical Group | Dallas | Texas | 75230 | — |
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030-4008 | — |
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 NCT02336737, 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 Nov 23, 2020 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02336737 live on ClinicalTrials.gov.