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Technetium Tc 99m Sulfur Colloid

Radiopharmaceuticals

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.

Sub-cutaneous injection of SiennaXP magnetic marker, followed by lymph node localization using the SentiMag handheld magnetic probe

SiennaXP

Injection of a single dose of radioisotope (Technetium Tc99m Sulfur Colloid)

Technetium Tc99m Sulfur Colloid

Injection of a single dose of isosulfan blue dye

Isosulfan blue dye

Michael D Alvarado, MD

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.

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.

SentiMag® Intraoperative Comparison in Breast Cancer

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

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

Number of Participants with Adverse Events relating to Sienna XP Injection

The number of nodes identified by both SiennaXP and Control out of nodes identified by Control

The per patient detection rate for a combination of all methods (magnetic, combined radioisotope and blue dye; radioisotope alone; blue dye alone)

Regulatory and Clinical Research Institute Inc

Endomagnetics Inc

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.

SiennaXP: Sub-cutaneous injection of SiennaXP magnetic marker, followed by lymph node localization using the SentiMag handheld magnetic probe

Technetium Tc99m Sulfur Colloid: Injection of a single dose of radioisotope (Technetium Tc99m Sulfur Colloid)

Isosulfan blue dye: Injection of a single dose of isosulfan blue dye

SiennaXP Injection

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.

SiennaXP: Sub-cutaneous injection of SiennaXP magnetic marker, followed by lymph node localization using the SentiMag handheld magnetic probe

Technetium Tc99m Sulfur Colloid: Injection of a single dose of radioisotope (Technetium Tc99m Sulfur Colloid)

Age, Categorical

Age, Continuous

Sex: Female, Male

Study subjects self-reported their ethnicity

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Clinical Develoment Director

146/147 were evaluated for the primary objective. One (1) subject had missing data and therefore was not included in the primary endpoint analysis

Number of Participants With Detected Lymph Nodes

Number of subjects experiencing Sienna XP injection-related adverse events from enrollment through subject exit or completion

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