SentiMag® Intraoperative Comparison in Breast Cancer (SentiMagIC)

Endomagnetics

Status: Completed

Conditions: Breast Cancer

Treatments: Device: SiennaXP; Drug: Isosulfan blue dye; Drug: Technetium Tc99m Sulfur Colloid

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02336737

US-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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160 participants in 1 patient group

SiennaXP injection

Experimental group

Description:

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.

Treatment:

Drug: Technetium Tc99m Sulfur Colloid

Drug: Isosulfan blue dye

Device: SiennaXP