Diagnostic Nodal Staging for Melanoma With Nuclear and Near-Infrared (NIR) Molecular Optical Imaging
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Percentage of Nodes Identified by Indocyanine Green (ICG) Among All Resected Lymph Nodes
研究概览
简要总结
Objectives:
- To determine the feasibility of using microdose amounts of near-infrared (NIR) fluorescent contrast agent to image tumor-draining and contralateral lymphatics in melanoma patients prior to standard-of-care sentinel lymph node biopsy OR completion lymph node dissection (axillary or inguinofemoral)
- To determine the feasibility of using nonradioactive optical imaging techniques with indocyanine green (ICG) as a fluorescent contrast agent to characterize lymphatic architecture and function by correlating the observed lymphatic structure and function with tumor and nodal status as determined from standard-of-care immunohistochemical evaluation.
详细描述
Indocyanine Green Injections:
IC-Green Injections:
If you are found to be eligible to take part in this study, you will receive a total of 10-16 injections of IC-Green through a needle in your arms or legs, starting in your hands or feet (5-8 on each arm/leg), depending on the location of the tumor. You may receive additional injections in the torso, if there is a tumor in the torso area and the study doctor thinks it is needed. The study doctor will discuss the number of injections that you will receive in more detail. The injections will be given to you before surgery and all injections will be given intradermally (into or between layers of the skin).
The IC-Green injections will allow researchers to see how fluid flows through your body during imaging. This information may help future researchers more easily locate lymph nodes in patients scheduled for lymph node surgery.
After all of the IC-Green injections have been given, the imaging procedure will begin. To perform the imaging procedures, researchers will use an experimental camera that shines a special red light onto your skin causing the IC-Green to glow when the images are taken. The red light is like the red light in a grocery store scanner. The imaging procedure will take about 1 hour to complete and will be performed before and during the surgery.
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 must be 18 years of age or older
- •Diagnosis of invasive melanoma with (ARM A) biopsy documenting a T2 (greater than 1 mm thickness) primary tumor undergoing standard of care sentinel lymph node biopsy (SLN) for definitive pathologic staging, OR (ARM B) documented node-positive (stage III) disease undergoing standard-of-care axillary or inguinofemoral lymph node dissection for regional disease control.
- •Negative urine pregnancy test within 72 hours prior to study drug administration, if female of childbearing potential.
- •Female of childbearing potential who agrees to use a medically accepted method of contraception for a period of one (1) month following the study. Medically acceptable contraceptives include (i) hormonal contraceptives such as birth control pills, Depo-Provera, or Lupron Depot) if such is approved by the subject's Oncologist; (ii) barrier methods (such as a condom or diaphragm used with a spermicide, or (iii) an intrauterine device (IUD). Non-childbearing potential is defined as physiologically incapable of becoming pregnant, including any female who is post-menopausal; postmenopausal is defined as the time after which a woman has experienced 12 consecutive months of amenorrhea (lack of menstruation).
- •For patients undergoing a complete axillary or inguinofemoral lymph node dissection a positive previous sentinel lymph node or a positive fine needle aspirate or core biopsy of their axillary or inguinofemoral lymph nodes.
排除标准
- •Women who are pregnant or breast-feeding.
- •Persons who are allergic to iodine
- •A female of child-bearing potential who does not agree to use an approved contraceptive for one month after study participation.
- •History of ipsilateral axillary or femoral surgery not including previous sentinel lymph node biopsy procedure.
- •Persons who do not meet inclusion criteria.
研究组 & 干预措施
IC-Green + Imaging
Indocyanine Green (IC-Green) Injections + Imaging
干预措施: Imaging (Procedure)
IC-Green + Imaging
Indocyanine Green (IC-Green) Injections + Imaging
干预措施: Indocyanine Green (IC-Green) (Drug)
结局指标
主要结局
Percentage of Nodes Identified by Indocyanine Green (ICG) Among All Resected Lymph Nodes
时间窗: 18-24 hours after procedure
Procedure feasible if 18 out of 24 evaluable patients have 80% or more nodes identified by ICG among all resected nodes. Descriptive analyses performed to report the mean percentage and its 95% confidence interval of the nodes identified by ICG among the total resected nodes of all evaluable subjects. Outcome will be tabulated by age, different tumor stage, nodal status, and body mass index.
次要结局
未报告次要终点