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临床试验/CTRI/2025/11/098114
CTRI/2025/11/098114尚未招募3 期

Validation of dual tracer Sentinel Lymph node biopsy in patients with non-metastatic in-breast tumour recurrence undergoing Re-surgery and study of lymphatic drainage pathways (SLR study)

NA1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2025年12月8日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
NA
入组人数
110
试验地点
1
主要终点
1. False Negative Rate

研究概览

简要总结

Breast cancer treatment and axillary (underarm lymph node) surgery have evolved over the years to become less extensive and more precise. Sentinel lymph node biopsy (SLNB) is now a standard method used to identify the first few lymph nodes that drain the breast and are most likely to contain cancer cells.

In some patients, breast cancer can recur in the same breast after the first surgery, known as ipsilateral breast tumour recurrence (IBTR). Managing the lymph nodes in such cases is challenging because prior surgery and radiotherapy may have altered the normal lymphatic drainage pathways. The standard treatment currently involves a complete axillary lymph node dissection (ALND), which can lead to higher rates of complications such as arm swelling (lymphedema).

This study, called the SLR study, aims to validate the use of a dual tracer technique (using a combination of radioactive tracer and blue dye) for identifying sentinel lymph nodes in patients with non-metastatic in-breast tumour recurrence who are undergoing repeat breast surgery. The study will also assess how lymphatic drainage pathways change after previous breast and axillary surgeries.

All eligible patients with confirmed non-metastatic breast cancer recurrence will undergo the dual tracer sentinel lymph node procedure, followed by standard axillary lymph node dissection. The study will evaluate the accuracy (false-negative rate) and identification rate of the repeat SLNB and will help improve understanding of lymphatic mapping in previously operated patients.

The results are expected to provide evidence on whether re-SLNB can safely replace full axillary clearance in selected patients and help reduce surgical morbidity while maintaining accurate staging.

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 70.00 Year(s)(—)
性别
Female

入选标准

  • All patients with histologically proven ipsilateral breast tumourrecurrence (non-metastatic) who have undergone SLNB or low axillary sampling (LAS) or ALND in their index surgery.
  • IBTR patients undergoing upfront surgery or post-chemotherapy surgery (re-BCS or completion mastectomy)
  • Above 18 years
  • Able to give written informed consent
  • Fit for surgery.

排除标准

  • Pregnant, lactating women
  • Patients allergic to methylene blue dye / radio colloid injection.

结局指标

主要结局

1. False Negative Rate

时间窗: After surgery

次要结局

  • 1. Identification rate of SLNB(2. Identification of first echelon SNB after previous breast surgery)

研究者

发起方
NA
申办方类型
Other [na]
责任方
Principal Investigator
主要研究者

Dr Shalaka Joshi

Tata Memorial Centre

研究点 (1)

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