NCT02336737

SentiMag® Intraoperative Comparison in Breast Cancer

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Endomagnetics Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a pivotal, prospective, open label, multicenter, paired comparison of the SentiMag® and SiennaXP® magnetic sentinel node localization system with the standard of care (radioisotope with blue dye) for lymph node localization in the detection of lymph nodes in patients with breast cancer undergoing a sentinel lymph node biopsy. The trial is designed to provide powered evidence that the lymph node detection rate of the SentiMag® and SiennaXP® system is non-inferior to the standard of care in patients with breast cancer.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DEVICE	SiennaXP	Sub-cutaneous injection of SiennaXP magnetic marker, followed by lymph node localization using the SentiMag handheld magnetic probe
DRUG	Technetium Tc99m Sulfur Colloid	Injection of a single dose of radioisotope (Technetium Tc99m Sulfur Colloid)
DRUG	Isosulfan blue dye	Injection of a single dose of isosulfan blue dye

Timeline

• Start date: 2015-01-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2015-01-13
• Last updated: 2020-11-23
• Results posted: 2020-11-03

Locations

6 sites across 1 country: United States