SentiMag® Intraoperative Comparison in Breast Cancer

Completed · Not applicable

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT02336737

Run by

Endomagnetics Inc

People needed

160

Starts

2015-01-01

Expected to finish

2015-12-01

Last updated by the study team

2020-11-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• 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, 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

Full record on ClinicalTrials.gov

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