Skip to main content
OpenTrials
Completed

NCT Number: NCT02336737

SentiMag® Intraoperative Comparison in Breast Cancer

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California San Diego Moores Cancer Center, La Jolla, California, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects with a diagnosis of primary breast cancer or subjects with pure ductal carcinoma in situ (DCIS).
  • Subjects scheduled for surgical intervention, with a sentinel lymph node biopsy procedure being a part of the surgical plan.
  • Subjects aged 18 years or more at the time of consent.
  • Subjects with an ECOG (Eastern Cooperative Oncology Group) performance status of Grade 0 - 2.
  • Subject has a clinical negative node status (i.e. T0-3, N0, M0).

Exclusion criteria

  • The subject is pregnant or lactating.
  • The subject has clinical or radiological evidence of metastatic cancer including palpably abnormal or enlarged lymph nodes.
  • The subject has a known hypersensitivity to Isosulfan Blue Dye.
  • The subject has participated in another investigational drug study within 30 days of scheduled surgery.
  • Subject has had either a) previous axilla surgery, b) reduction mammoplasty, or c) lymphatic function that is impaired in the surgeon's judgment.
  • Subject has had preoperative radiation therapy to the affected breast or axilla.
  • Subject has received a Feraheme® (ferumoxytol) Injection within the past 6 months.
  • Subject has intolerance or hypersensitivity to iron or dextran compounds or to SiennaXP.
  • Subject has an iron overload disease.
  • Subject has pacemaker or other implantable device in the chest wall.

Treatment and study plan

SiennaXP

Device

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

Technetium Tc99m Sulfur Colloid

Drug

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

Other names: Radioisotope

Isosulfan blue dye

Drug

Injection of a single dose of isosulfan blue dye

Other names: Blue dye

Primary outcomes

  1. Number of Participants With Detected Lymph Nodes

    Time frame: During surgical procedure <1 hour

    The proportion of lymph nodes detected intraoperatively by SentiMag and SiennaXP in relation the proportion of lymph nodes detected by the combination of Technetium Sulfur Colloid and Isosulfan blue dye

  2. Safety of SiennaXP and SentiMag® as Indicated by Adverse Events and Serious Adverse Events and Their Relatedness to the Detection Method or Procedure.

    Time frame: 3-6 weeks

    Number of Participants with Adverse Events relating to Sienna XP Injection

Secondary outcomes

  1. Nodal Concordance: Number of Nodes Identified by Both Test and Control Out of Nodes Identified by Control

    Time frame: Intraoperative <1 hour

    The number of nodes identified by both SiennaXP and Control out of nodes identified by Control

  2. Number of Participants With Lymph Nodes Detected by Combined Radioisotope,Blue Dye and Magnetic Technique

    Time frame: Intraoperative <1 hour

    The per patient detection rate for a combination of all methods (magnetic, combined radioisotope and blue dye; radioisotope alone; blue dye alone)

Sponsors and collaborators

Lead sponsor

Endomagnetics Inc

Industry

Collaborators

  • Regulatory and Clinical Research Institute Inc

Registry information

Official study 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

Acronym: SentiMagIC

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jan 13, 2015
Registry last updated
Nov 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.