A Preliminary Study To Explore Subareolar Injection As The Site For Lymphatic Mapping And Sentinel Lymph Node Biopsy In Patients With Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Lymphatic drainage patterns as determined by peritumoral and subareolar injections
研究概览
简要总结
RATIONALE: Diagnostic procedures, such as lymphoscintigraphy using an injection under the nipple or near the tumor, may help doctors find out how far the disease has spread.
PURPOSE: This clinical trial is studying two different injection methods to compare how well they find the sentinel lymph node during lymphatic mapping and sentinel lymph node biopsy in patients with invasive breast cancer.
详细描述
OBJECTIVES:
- Compare subareolar injection with peritumoral injection in identifying the sentinel node during breast lymphatic mapping in patients with invasive breast cancer.
- Compare the lymphatic drainage patterns using lymphoscintigraphy of the breast with subareolar injection vs peritumoral injection.
OUTLINE: At least 2 days before scheduled surgery, patients receive technetium Tc 99m sulfur colloid by peritumoral injection followed by lymphoscintigraphy. Images are obtained at 30 minutes and after 2 and 3 hours, provided no drainage is noted. Patients then receive technetium Tc 99m sulfur colloid by subareolar injection followed by another lymphoscintigraphy.
At the time of surgery, patients receive isosulfan blue by subareolar injection. A handheld gamma probe is used to locate the sentinel node. If the sentinel node is identified, it is excised and the scheduled breast surgery is performed. If the sentinel node cannot be identified, patients undergo the scheduled breast surgery.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 12.5 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have either pathologic, radiologic or clinical evidence of breast cancer with invasion, suspicious for invasion or microinvasion.
- •Patients who are candidates for a total mastectomy or segmental mastectomy or axillary dissection.
- •Patients who have undergone neoadjuvant chemotherapy who have an FNA confirmed lymph node positive for metastatic disease prior to induction chemotherapy and are then found to have grossly palpable disease but are ultrasound node negative at time of study entry.
- •Patients must sign an informed consent and be registered before the procedure is performed.
排除标准
- •A pregnancy test will be required preoperatively in women of childbearing potential and patients who are pregnant will be excluded from this study.
- •Patients who have undergone neoadjuvant chemotherapy who have an FNA confirmed lymph node metastatic disease prior to induction chemotherapy and are then found to have grossly suspicious palpable disease and are ultrasound node positive at the time of study entry.
- •Patients with known allergy to isosulfan blue dye or any related compounds.
研究组 & 干预措施
Injection Methods
One injection site with radioactive tracer intraparenchymal/peritumoral (around the tumor), and other subareolar (around the nipple)
干预措施: Isosulfan Blue (Drug)
Injection Methods
One injection site with radioactive tracer intraparenchymal/peritumoral (around the tumor), and other subareolar (around the nipple)
干预措施: Lymphangiography (Procedure)
Injection Methods
One injection site with radioactive tracer intraparenchymal/peritumoral (around the tumor), and other subareolar (around the nipple)
干预措施: Technetium Tc 99m sulfur colloid (Radiation)
结局指标
主要结局
Lymphatic drainage patterns as determined by peritumoral and subareolar injections
时间窗: 12 months to collect data
Evaluate outcome descriptively.
Identification rate of sentinel nodes and negative predictive value associated with subareolar injection
时间窗: 12 months to collecte data
Evaluate outcome descriptively.
次要结局
未报告次要终点