A Pilot Study to Assess the Utility of Indocyanine Green™ (IC-GREEN™) SPY Imaging in the Mapping of Arm Draining Lymphatics and Nodes During Sentinel Node Resection With or Without Axillary Dissection in Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Agreement of Labeling Between Isosulfan Blue (IS-BLUE) and Indocyanine Green (IC-GREEN)
研究概览
简要总结
The purpose of this study is to determine if Indocyanine Green (IC-GREEN) is comparable to isosulfan blue (IS-BLUE) in the identification of arm lymphatics and arm-draining nodes during nodal staging procedures in breast cancer.
详细描述
It is the objective of the current study to test Indocyanine Green (IC-GREEN) as an agent for mapping arm draining lymphatics and nodes and compare it to isosulfan blue (IS-BLUE) in the setting of sentinel node procedures with or without axillary node dissections in women with breast cancer. All participants will also have tumor samples evaluated with 99technetium-sulfur colloid, a radiolabel used to identify tumor markers.
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 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Ability to understand and the willingness to sign a written informed consent document.
- •Signed written informed consent.
- •Women undergoing sentinel lymph node biopsy.
- •Women with breast cancer with known or suspected lymph node involvement.
- •Women undergoing sentinel node identification and completion axillary lymph node dissection.
- •Women of 18 years of age or older.
- •Eastern Cooperative Oncology Group (ECOG) or Karnofsky Performance Status 0,1,
- •Complete Blood Count (CBC) and basic Metabolic Panel within 6 months
排除标准
- •History of liver or kidney failure will not be eligible.
- •Allergies to iodine containing products will not be eligible.
- •Women who are pregnant will not be eligible.
- •Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.
研究组 & 干预措施
ISB and ICG
The dose of Isosulfan blue (ISB) dye and Indocyanine green (ICG) solution will be started.
(IC-GREEN) SPY Elite Imaging willbe used to capture the images of axillary cavity.
干预措施: SPY Elite Imaging (Device)
ISB and ICG
The dose of Isosulfan blue (ISB) dye and Indocyanine green (ICG) solution will be started.
(IC-GREEN) SPY Elite Imaging willbe used to capture the images of axillary cavity.
干预措施: Indocyanine Green (Drug)
ISB and ICG
The dose of Isosulfan blue (ISB) dye and Indocyanine green (ICG) solution will be started.
(IC-GREEN) SPY Elite Imaging willbe used to capture the images of axillary cavity.
干预措施: Isosulfan blue (Drug)
ISB and ICG
The dose of Isosulfan blue (ISB) dye and Indocyanine green (ICG) solution will be started.
(IC-GREEN) SPY Elite Imaging willbe used to capture the images of axillary cavity.
干预措施: 99technetium-sulfur colloid radiolabel (Drug)
结局指标
主要结局
Agreement of Labeling Between Isosulfan Blue (IS-BLUE) and Indocyanine Green (IC-GREEN)
时间窗: 1 day
Number of women with agreement of the two dies \[ie, isosulfan blue (IS-BLUE) and indocyanine green (IC-GREEN)\] on all nodes examined in the lymphatics and arm-draining lymph nodes, during nodal staging procedures for surgery to treat breast cancer with curative intent.
次要结局
- Detection of Indocyanine Green (IC-GREEN); Isosulfan Blue (IS-BLUE); and 99technetium-sulfur Colloid Radiolabel in Resected Sentinel Nodes(1 day)
研究者
Irene L. Wapnir
Professor - Med Center Line, Surgery - General Surgery
Stanford University