SentiMag® Intraoperative Comparison in Breast Cancer (SentiMagIC)

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

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 Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Device: SiennaXP; Drug: Technetium Tc99m Sulfur Colloid; Drug: Isosulfan blue dye

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.

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92093-0698
      • University of California San Diego Moores Cancer Center
    • Sacramento, California, United States, 95817
      • University of California Davis Comprehensive Cancer Center
    • San Francisco, California, United States, 94115
      • UCSF Carol Franc Buck Breast Care Center
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18104
      • Coordinated Health Breast Care Specialists
  • Texas
    • Dallas, Texas, United States, 75230
      • Dallas Surgical Group
    • Houston, Texas, United States, 77030-4008
      • University of Texas MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SiennaXP injection; Single injection of SiennaXP in addition to comparator single dose of radioisotope (Technetium Tc99m Sulfur Colloid) and single dose of isosulfan blue dye. Lymph node localization using the SentiMag handheld intraoperative localization system in addition to localization with standard of care handheld gamma probe.	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); Other Names: Radioisotope; Drug: Isosulfan blue dye; Injection of a single dose of isosulfan blue dye; Other Names: Blue dye

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Detected Lymph Nodes	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	During surgical procedure <1 hour
Safety of SiennaXP and SentiMag® as Indicated by Adverse Events and Serious Adverse Events and Their Relatedness to the Detection Method or Procedure.	Number of Participants with Adverse Events relating to Sienna XP Injection	3-6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nodal Concordance: Number of Nodes Identified by Both Test and Control Out of Nodes Identified by Control	The number of nodes identified by both SiennaXP and Control out of nodes identified by Control	Intraoperative <1 hour
Number of Participants With Lymph Nodes Detected by Combined Radioisotope,Blue Dye and Magnetic Technique	The per patient detection rate for a combination of all methods (magnetic, combined radioisotope and blue dye; radioisotope alone; blue dye alone)	Intraoperative <1 hour

Collaborators and Investigators

• Sponsor: Endomagnetics Inc
• Collaborators: Regulatory and Clinical Research Institute Inc
• Investigators: Principal Investigator: Michael D Alvarado, MD, University of CA, San Francisco Carol Franc Buck Breast Care, Dept of Surgery

Publications and helpful links

General Publications

• Douek M, Klaase J, Monypenny I, Kothari A, Zechmeister K, Brown D, Wyld L, Drew P, Garmo H, Agbaje O, Pankhurst Q, Anninga B, Grootendorst M, Ten Haken B, Hall-Craggs MA, Purushotham A, Pinder S; SentiMAG Trialists Group. Sentinel node biopsy using a magnetic tracer versus standard technique: the SentiMAG Multicentre Trial. Ann Surg Oncol. 2014 Apr;21(4):1237-45. doi: 10.1245/s10434-013-3379-6. Epub 2013 Dec 10.
• Thill M, Kurylcio A, Welter R, van Haasteren V, Grosse B, Berclaz G, Polkowski W, Hauser N. The Central-European SentiMag study: sentinel lymph node biopsy with superparamagnetic iron oxide (SPIO) vs. radioisotope. Breast. 2014 Apr;23(2):175-9. doi: 10.1016/j.breast.2014.01.004. Epub 2014 Jan 29.

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: January 7, 2015
• First Submitted That Met QC Criteria: January 8, 2015
• First Posted (Estimate): January 13, 2015

Study Record Updates

• Last Update Posted (Actual): November 23, 2020
• Last Update Submitted That Met QC Criteria: November 6, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: breast cancer; sentinel lymph node biopsy
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Molecular Mechanisms of Pharmacological Action; Radiopharmaceuticals; Technetium Tc 99m Sulfur Colloid
• Other Study ID Numbers: US-001