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临床试验/CTRI/2024/09/074039
CTRI/2024/09/074039尚未招募3 期

Use of Indocyanine green (ICG) dye for Sentinel lymph node biopsy in Breast cancer patients

Father Muller Research Centre1 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2024年9月30日最近更新:

试验速览

阶段
3 期
状态
尚未招募
入组人数
59
试验地点
1
主要终点
Identification of sentinel nodes( identification rate) and their pathological assessment ( positive rate) by frozen section.

研究概览

简要总结

Breast cancer is on the rise in India and there is a dearth of awareness of the problem and its consequences in our society. Axillary lymph node status provides important prognostic information in invasive breast cancer. Management of involved axilla has evolved over time. Fisher et al were the first to support the hypothesis that axillary dissection has prognostic significance. This led to the use of various options in the management of axilla including axillary lymph node dissection (ALND), axillary clearance, axillary dissection with regional lymph node radiation, regional radiation alone, axillary sampling, sentinel lymph node biopsy (SLNB) and observation only.SLNB can be done using various dyes such as methyelene blue, fluroscein, radiocolloid, indocyanine green(ICG). Using ICG dye, the sentinel node can be visualised   using infrared light. With the intention of making SLNB as a standard procedure of choice we want to conduct a validation study using ICG for identification of sentinel node and by frozen section method followed by Axillary lymph node dissection in all patients there by assessing the accuracy, safety, and feasibility of SLNB in breast cancer patients at our institution.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
Female

入选标准

  • upfront operable breast cancer patients.

排除标准

  • Known allergy to iodine/ ICG
  • Post neo-adjuvant chemotherapy patients
  • Patients refusing for the study
  • Pregnancy associated breast cancer.

结局指标

主要结局

Identification of sentinel nodes( identification rate) and their pathological assessment ( positive rate) by frozen section.

时间窗: 1 year

次要结局

  • safety(feasibility)

研究者

申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Jnaneshwari Jayaram

Father Muller Medical College,

研究点 (1)

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