Lymphatic and Systemic Immunity Changes in Post-radiation Lymphedema Development
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Percent extravascular dye as assessed by NIRFLI
研究概览
简要总结
The goal of this study is to find out which immune molecules, cells, and genes are involved in the development of lymphedema (LE), so that medicines that target them can be considered for treating lymphedema. The hypothesis is that LE is a systemic, autoimmune-like disease that is initiated by inflammatory cytokines induced by surgery, radiation, and possibly chemotherapy in genetically susceptible patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Participants must be at least 18 years of age
- •Participants must have been clinically diagnosed with breast cancer and scheduled for axillary lymph node dissection (ALND) and radiation treatment at MD Anderson (receiving chemotherapy, mastectomy or breast-conserving surgery, ALND (>10 nodes) and radiation treatment for breast cancer, identified by Drs. Mittendorf and Shaitelman of the Nellie B. Connally Breast Cancer Center at MD Anderson)
- •Ambulatory and possessing all four limbs
- •No prior radiation therapy
- •Negative urine pregnancy test within 36 hours prior to study drug administration, if of childbearing potential
- •Females participants must complete the Female Enrollment Form. Childbearing potential participants must agree to use one of the medically accepted forms of contraception for a period of one month after study participation. Female participants who meet the criteria for non-childbearing will still complete the Female Enrollment Form, but are not restricted to the use of contraception following study participation.
排除标准
- •Participants with a known or suspected allergy to iodine
- •Participants who are breastfeeding, pregnant or trying to become pregnant
- •Severe underlying chronic illness or disease (other than breast cancer)
- •Participants not capable of keeping moderately still for the imaging portion of the study session (~1 hour for imaging)
研究组 & 干预措施
Cancer-treated patients receiving NIRFLI
Near-infrared Fluorescence Lymphatic Imaging (NIRFLI) using Indocyanine Green (ICG) is used to "visualize" lymphatic vessel anatomy and function.
干预措施: Indocyanine Green (ICG) (Drug)
Cancer-treated patients receiving NIRFLI
Near-infrared Fluorescence Lymphatic Imaging (NIRFLI) using Indocyanine Green (ICG) is used to "visualize" lymphatic vessel anatomy and function.
干预措施: Near-infrared Fluorescence Lymphatic Imaging (NIRFLI) (Device)
结局指标
主要结局
Percent extravascular dye as assessed by NIRFLI
时间窗: 24 months after radiation
Vessel tortuosity as assessed by NIRFLI
时间窗: 24 months after radiation
Vessel dilation ratio as assessed by NIRFLI
时间窗: 24 months after radiation
Lymphatic propulsive frequency as assessed by NIRFLI
时间窗: 24 months after radiation
Lymphatic propulsive velocity as assessed by NIRFLI
时间窗: 24 months after radiation
次要结局
- Number of participants with autoimmune antibodies as assessed by ELISA(24 months after radiation)
- Chemokine levels as assessed by bead assay(24 months after radiation)
- Cytokine levels as assessed by bead assay(24 months after radiation)
研究者
Melissa B Aldrich
Assistant Professor
The University of Texas Health Science Center, Houston