CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 160 enrolled
Drug / intervention
Technetium Tc99m Sulfur Colloid +2 moredrug
Likely dose
Not stated in 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/NCT02336737
NCT02336737N/ACompleted
CompareCT.gov

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

Endomagnetics Inc·interventional·Posted Jan 13, 2015·Updated Nov 23, 2020

In Brief

A clinical study evaluating SiennaXP, Technetium Tc99m Sulfur Colloid, and 1 other intervention for Breast Cancer. Completed, enrolled 160 participants across 6 sites.

Detailed Summary

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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States
CollaboratorsRegulatory and Clinical Research Institute Inc

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedJan 13, 2015
Enrollment StartJan 1, 2015
Primary CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 11.5 years ago

Interventions

SiennaXPdevice

Sub-cutaneous injection of SiennaXP magnetic marker, followed by lymph node localization using the SentiMag handheld magnetic probe

Technetium Tc99m Sulfur Colloiddrug

Injection of a single dose of radioisotope (Technetium Tc99m Sulfur Colloid)

Isosulfan blue dyedrug

Injection of a single dose of isosulfan blue dye