NCT03200704已完成3 期
Single Arm, Prospective, Open Label, Multicenter Study Assessing the Safety and Effectiveness of IC2000 and SPY Fluorescence Imaging Systems in the Visualization of Lymphatic Vessels and Lymph Nodes During Lymphatic Mapping and Sentinel Lymph Node Biopsy in Subjects With Breast Cancer
Novadaq Technologies ULC, now a part of Stryker14 个研究点 分布在 2 个国家目标入组 152 人开始时间: 2019年1月4日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 152
- 试验地点
- 14
- 主要终点
- Proportion of Lymph Nodes Identified by IC2000/SPY-PHI Compared to the Proportion of Lymph Nodes Identified by Tc99m/Gamma Probe
研究概览
简要总结
This is a prospective, open label, multicenter, non-inferiority within-patient study to determine the effectiveness of IC2000 (Indocyanine Green (ICG) for Injection) and the SPY Portable Handheld Imaging System (SPY-PHI) as an intraoperative fluorescence visualization tool, in the visual identification of lymphatic vessels and lymph nodes (LNs) during lymphatic mapping and sentinel lymph node biopsy (SLNB) procedures as confirmed by Technitium99m (Tc99m) and Gamma Probe.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Be 18 years of age or older
- •Subjects with American Cancer Society Clinical Stage 0 Ductal Carcinoma in Situ (DCIS) (Stage 0, Tis, N0, M0), IA (T1*, N0, M0), IB ((T0, N1mi, M0) or T1*, N1mi, M0)) or Stage IIA (T0, N1**M0, or T1, N1**, M0 or T2, N0, M0)1 breast cancer undergoing surgery to remove tumor draining LNs.
- •Tis = Ductal carcinoma in situ
- •T0 = No evidence of primary tumor
- •T1 = Tumor ≤ 20 mm in greatest diameter
- •T1* = Includes T1mi
- •T2 = Tumor >20 mm but ≤ 50 mm in greatest diameter
- •N0 = No regional lymph node metastasisq1'
- •N1 = Metastasis to movable ipsilateral level I, II axillary LNs
- •N1** = T0 and T1 tumors with nodal micro-metastasis only are excluded from Stage IIA and are classified Stage IB.
- •mi = Micro-metastasis
- •M0 = Disease has not metastasized from Stage IIA and are classified Stage IB.
- •M0= No evidence of metastasis
- •mi= Micrometastasis
- •Subjects with clinically negative nodal status (N0) with or without neoadjuvant chemotherapy
- •Subjects with negative metastatic involvement (M0)
- •Subjects of child-bearing potential must not be pregnant or lactating and must have a negative pregnancy test at Baseline
- •Have signed an approved informed consent form for the study
- •Be willing to comply with the protocol
排除标准
- •Have had prior axillary surgery or ipsilateral radiation in the breast(s) that is planned for the procedure
- •Advanced breast cancer subjects with stage IIB, III and IV
- •Known allergy or history of adverse reaction to ICG, iodine or iodine dyes
- •Subjects who have participated in another investigational study within 30 days prior to surgery
- •Pregnant or lactating subject
- •Subjects who, in the Investigator's opinion, have any medical condition that makes the subject a poor candidate for
结局指标
主要结局
Proportion of Lymph Nodes Identified by IC2000/SPY-PHI Compared to the Proportion of Lymph Nodes Identified by Tc99m/Gamma Probe
时间窗: From Technetium-99 (Tc-99m) injection to the completion of surgery
次要结局
- Proportion of Lymph Nodes Identified by IC2000/SPY-PHI by Following a Fluorescent Lymphatic Vessel, and the Proportion of Identified Lymph Nodes With no Lymphatic Vessels Visible by IC2000/SPY-PHI(From Technetium-99 (Tc-99m) injection to the completion of surgery)
- To Assess the Safety of Intradermal Injection of IC2000(From Technetium-99 (Tc-99m) injection to the completion of surgery)
- Proportion of Subjects With at Least One Lymph Node Identified by IC2000/SPY-PHI, and the Proportion of Subjects With at Least One Lymph Node Identified by Tc99m/Gamma Probe(From Technetium-99 (Tc-99m) injection to the completion of surgery)
研究者
研究点 (14)
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