Sentinel Lymph Node Localization and Biopsy for Sebaceous Gland Carcinoma of the Eyelid
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Sentinel Lymph Node Positivity
研究概览
简要总结
This phase II trial studies how well lymph node mapping works in finding disease that has spread from the place where it started to other places in the body in patients with sebaceous gland cancer of the eyelid. Lymph node mapping may help in planning surgery to remove cancer and affected lymph nodes.
详细描述
PRIMARY OBJECTIVES:
I. Identify the rate of SLN (sentinel lymph node) positivity for eyelid sebaceous gland carcinomas.
II. Identify the false negative events associated with SLN biopsy for sebaceous gland carcinomas.
SECONDARY OBJECTIVE:
I. Record any side effects associated with SLN biopsy for sebaceous gland carcinoma of the eyelid.
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
- •Possible or suspicious sebaceous gland carcinoma of the eyelid
- •A CXR (chest x-ray), liver enzymes, and a head and neck computed tomography (CT), a single photon emission computed tomography (SPECT/CT) or magnetic resonance imaging (MRI) and an ultrasound negative for clinical evidence of metastasis
- •Patient provided written informed consent; in the event that non-English speaking participants are eligible for this study, a short form (if applicable) or an informed consent document (ICD) in their language, will be utilized and completed in accordance with the M.D. Anderson Cancer Center (MDACC) Policy for Consenting Non-English Speaking Participants
排除标准
- •Pregnant or nursing females
研究组 & 干预措施
Diagnostic (SLN localization and biopsy)
Patients receive technetium Tc 99m sulfur colloid ID and then undergo lymph node mapping and SLN biopsy.
干预措施: Lymph Node Mapping (Procedure)
Diagnostic (SLN localization and biopsy)
Patients receive technetium Tc 99m sulfur colloid ID and then undergo lymph node mapping and SLN biopsy.
干预措施: Sentinel Lymph Node Biopsy (Procedure)
Diagnostic (SLN localization and biopsy)
Patients receive technetium Tc 99m sulfur colloid ID and then undergo lymph node mapping and SLN biopsy.
干预措施: Technetium Tc-99m Sulfur Colloid (Drug)
结局指标
主要结局
Sentinel Lymph Node Positivity
时间窗: One year after the surgical procedure under study.
Number of patients who had a positive sentinel lymph node
次要结局
未报告次要终点