SentiMag® Intraoperative Comparison in Breast Cancer

Breast Cancer Clinical Trial

— SentiMagIC  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02336737
• Other study ID #: US-001
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: December 2015

Study information

• Verified date: November 2020
• Source: Endomagnetics Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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)
• Isosulfan blue dye
Injection of a single dose of isosulfan blue dye

Locations

Country	Name	City	State
United States	Coordinated Health Breast Care Specialists	Allentown	Pennsylvania
United States	Dallas Surgical Group	Dallas	Texas
United States	University of Texas MD Anderson Cancer Center	Houston	Texas
United States	University of California San Diego Moores Cancer Center	La Jolla	California
United States	University of California Davis Comprehensive Cancer Center	Sacramento	California
United States	UCSF Carol Franc Buck Breast Care Center	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
Endomagnetics Inc	Regulatory and Clinical Research Institute Inc

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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