Spots Global Cancer Trial Database for SentiMag® Intraoperative Comparison in Breast Cancer
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Trial Identification
Brief Title: SentiMag® Intraoperative Comparison in 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
Study ID: NCT02336737
Conditions
Study Description
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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Contact Details
Name: Michael D Alvarado, MD
Affiliation: University of CA, San Francisco Carol Franc Buck Breast Care, Dept of Surgery
Role: PRINCIPAL_INVESTIGATOR
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