SentiMag® Intraoperative Comparison in Breast Cancer

Study Overview
=================
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.

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

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Device: SiennaXP
* Drug: Technetium Tc99m Sulfur Colloid
* Drug: Isosulfan blue dye


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SiennaXP injection<br>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<br>* Sub-cutaneous injection of SiennaXP magnetic marker, followed by lymph node localization using the SentiMag handheld magnetic probe<br>Drug: Technetium Tc99m Sulfur Colloid<br>* Injection of a single dose of radioisotope (Technetium Tc99m Sulfur Colloid)<br>* Other names: Radioisotope;Drug: Isosulfan blue dye<br>* Injection of a single dose of isosulfan blue dye<br>* 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breast cancer, sentinel lymph node biopsy