Testing the Efficacy of Indocyanine Green Imaging (ICG-SPY) in the Identification of Sentinel Lymph Nodes (SLN) in Patients With Malignant Melanoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Sentinel Lymph Nodes (SLN) Mapping
研究概览
简要总结
This clinical trial compares and contrasts lymph node mapping using indocyanine green (IC-GREEN), isosulfan blue (ISB), and TSC and Lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC).
Study participants with malignant melanoma will undergo all 3 evaluations to assess the extent of the spread of the melanoma.
详细描述
PRIMARY OBJECTIVES:
I. To show that indocyanine green (ICG) (indocyanine green solution) is equal to both isosulfan blue (ISB) and technetium Tc 99m sulfur colloid (TSC) and will allow all lymph node mapping to occur in the operating room (OR).
OUTLINE:
Patients receive peri-tumoral, intradermal injections of isosulfan blue and indocyanine green solution. During surgery, patients undergo identification of the sentinel lymph node and imaging using a laser with videocamera (SPY Elite camera).
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
- •Ability to understand and willingness to sign informed consent document
- •Signed written informed consent
- •Malignant melanoma (MM) undergoing sentinel lymph node biopsy (SNLB)
- •18 years of age or older
- •Complete blood count (CBC) and metabolic panel within 6 months
排除标准
- •History of hepatic or renal failure
- •Allergy to iodine containing products
- •Pregnant or may be pregnant
- •Psychiatric or addictive disorders that in the opinion of the research team, may not be able to meet study requirements
- •Undergoing dialysis
研究组 & 干预措施
Sentinel Lymph Node (SLN) Detection
All patients receive peri-tumoral, intradermal injections of isosulfan blue and indocyanine green solution for detection of melanoma in lymph nodes. In addition, lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC) will be conducted for all participants with the same objective.
干预措施: Lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC) (Diagnostic Test)
Sentinel Lymph Node (SLN) Detection
All patients receive peri-tumoral, intradermal injections of isosulfan blue and indocyanine green solution for detection of melanoma in lymph nodes. In addition, lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC) will be conducted for all participants with the same objective.
干预措施: Indocyanine green solution (Drug)
Sentinel Lymph Node (SLN) Detection
All patients receive peri-tumoral, intradermal injections of isosulfan blue and indocyanine green solution for detection of melanoma in lymph nodes. In addition, lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC) will be conducted for all participants with the same objective.
干预措施: Isosulfan blue (ISB) (Drug)
结局指标
主要结局
Sentinel Lymph Nodes (SLN) Mapping
时间窗: Up to 1 year
Sentinel lymph nodes (SLN) will be identified and mapped using indocyanine green (ICG) solution, isosulfan blue (ISB) solution, and TSC lymphoscintigraphy.
次要结局
未报告次要终点
研究者
Ralph Greco
Johnson and Johnson Professor of Surgery
Stanford University