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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 6
- 主要终点
- Number of Participants With Detected Lymph Nodes
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 -
- •Subject has a clinical negative node status (i.e. T0-3, N0, M0).
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Technetium Tc99m Sulfur Colloid (Drug)
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.
干预措施: SiennaXP (Device)
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.
干预措施: Isosulfan blue dye (Drug)
结局指标
主要结局
Number of Participants With Detected Lymph Nodes
时间窗: During surgical procedure <1 hour
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
Safety of SiennaXP and SentiMag® as Indicated by Adverse Events and Serious Adverse Events and Their Relatedness to the Detection Method or Procedure.
时间窗: 3-6 weeks
Number of Participants with Adverse Events relating to Sienna XP Injection
次要结局
- Nodal Concordance: Number of Nodes Identified by Both Test and Control Out of Nodes Identified by Control(Intraoperative <1 hour)
- Number of Participants With Lymph Nodes Detected by Combined Radioisotope,Blue Dye and Magnetic Technique(Intraoperative <1 hour)