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临床试验/CTRI/2025/05/087545
CTRI/2025/05/087545尚未招募2 期

Comprasion of methods of margin delineation for vaccum-assisted excision in Breast cancer patients with radilogical complete response post neoadjuvant chemotherapy

AIl India Institute of Medical Sciences Delhi1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年6月4日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
Feasibility, concordance with surgical pathology

研究概览

简要总结

Breast cancer is currently the most common cancer among women in India, with most cases being diagnosed at advanced stages. There is a growing role of NACT for management of breast cancer with some chemotherapy resulting in complete disappearance of the mass on preoperative imaging. However, a radiological complete response may not corroborate with pathological complete response in about 60% of patients, necessitating the need for surgical resection of the tumour bed.

Ultrasound or Mammography guided Vacuum Assisted tumour bed Excision (VAE) is an attractive minimally invasive option for tumor resection in certain scenarios like in patients with complete radiological response which is under investigation worldover to prove or disprove complete pathological response. Several studies indicate that adequate Vacuum Assisted Excision can accurately determine whether pathological complete response has been achieved, thus introducing the possibility of surgical deescalation. However since vacuum involves suction of tissue, margin determination is impossible.

However,  accurate excision of the entire tumor bed with adequate margin determination is important to prevent local recurrence which however is quite challenging at present. We propose and compare two methods of margin determination for VAE along with protocol for performing VAE. The 1st method is using two wires for bracketing the tumor bed t. The 2nd approach utilizes multidirectional VAE in the epicenter of tumor bed and a fixed predetermined distance around it for adequate excision. Additionally, we also propose to collect the data of the patient for development of machine learning techniques to identify the margins of the tumor bed in real time and thus guide VAE. .

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
25.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

  • Patients with breast cancer who have undergone NACT and have a complete response on mammography and ultrasound.
  • Patients in whom breast localisation clip has been placed.

排除标准

  • Patients with extensive intraductal components on initial biopsy.
  • Patients with extensive microcalcifications on initial mammography in addition to mass.
  • Patients without accurate localisation by means of a clip, in whom mass cannot be accurately localised on mammogram after NACT.

结局指标

主要结局

Feasibility, concordance with surgical pathology

时间窗: Time point is at the time of surgery in both cases, which is atleast 2 weeks after completion of NACT

次要结局

  • n/a(n/a)

研究者

发起方
AIl India Institute of Medical Sciences Delhi
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Krithika Rangarajan

AIIMS, Delhi

研究点 (1)

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