SentiMag® Intraoperative Comparison in Breast Cancer

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Device: SiennaXP; Drug: Technetium Tc99m Sulfur Colloid; Drug: Isosulfan blue dye

• Registration Number: NCT02336737
• Lead Sponsor: Endomagnetics Inc

Brief 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.

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-01-07
• Study First Submitted QC: 2015-01-08
• Study First Posted: 2015-01-13
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Disposition First Submitted: 2017-02-06
• Disposition First Submitted QC: 2017-02-06
• Disposition First Posted: 2017-02-07
• Results First Submitted: 2020-08-12
• Results First Submitted QC: 2020-10-09
• Status Verified: 2020-11
• Results First Posted: 2020-11-03
• Last Update Submitted: 2020-11-06
• Last Update Posted: 2020-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SiennaXP injection	SiennaXP	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.
SiennaXP injection	Isosulfan blue dye	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.
SiennaXP injection	Technetium Tc99m Sulfur Colloid	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Detected Lymph Nodes	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
Safety of SiennaXP and SentiMag® as Indicated by Adverse Events and Serious Adverse Events and Their Relatedness to the Detection Method or Procedure.	3-6 weeks	Number of Participants with Adverse Events relating to Sienna XP Injection

Secondary Outcome Measures

Name	Time	Method
Nodal Concordance: Number of Nodes Identified by Both Test and Control Out of Nodes Identified by Control	Intraoperative <1 hour	The number of nodes identified by both SiennaXP and Control out of nodes identified by Control
Number of Participants With Lymph Nodes Detected by Combined Radioisotope,Blue Dye and Magnetic Technique	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)

Trial Locations

Locations (6)

Coordinated Health Breast Care Specialists; 🇺🇸 Allentown, Pennsylvania, United States

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

UCSF Carol Franc Buck Breast Care Center; 🇺🇸 San Francisco, California, United States

University of California Davis Comprehensive Cancer Center; 🇺🇸 Sacramento, California, United States

Dallas Surgical Group; 🇺🇸 Dallas, Texas, United States

University of Texas MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States