SentiMag® Intraoperative Comparison in Breast Cancer

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Endomagnetics Inc
• Collaborator: Regulatory and Clinical Research Institute Inc
• Treatments: Technetium Tc 99m Sulfur Colloid

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.