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临床试验/NCT05887154
NCT05887154尚未招募不适用

Minimal Invasive Microwave Ablation in Early Stage breaST cancER, a Feasibility Study

University Medical Center Groningen0 个研究点目标入组 15 人开始时间: 2023年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
15
主要终点
MWA followed by MRI in breast tumors

研究概览

简要总结

In the Netherlands approximately one out of seven women will develop breast cancer during her life. Most of these breast cancers are early stage, 40% of the women have stage 1. Stage 1 breast cancer means that the cancer is small (size <2cm) and only in the breast tissue or it might be found in lymph nodes close to the breast. The standard treatment for stage 1 breast cancer is breast conserving surgery (BCS), sentinel lymph node procedure (SLNP) and additional radiotherapy. This standard treatment protocol results in a10 years survival rate of 95% for stage 1 disease. However, nowadays there is a discussion whether these early stage breast cancer could be treated less invasively. To reduce the invasiveness of breast cancer treatment, without compromising breast cancer specific survival, minimally invasive ablation procedure of the breast tumor can be an option for small breast lesions.

Patients with a tumor size<2 cm will undergo ultra guided microwave ablation (MWA) with local anesthesia. After a small incision 2-3 millimeters, an MWA electrode is placed at the end of the tumor with ultrasound guidance. The microwaves in MWA create heat around the needle and destroy the cancer cells. There are several advantages of ablation procedures: it is a minimal invasive technique, with a small or absent cutaneous scar and thereby potentially improving patient quality of life. Furthermore, ablative treatment can be done under local anesthesia and/or conscious sedation instead of general anesthesia and in daycare setting, which can reduce treatment cost. A post procedural MRI (after ablation) can determine whether the ablation procedure of the tumor volume is complete. The purpose of this study is to assess whether minimally invasive microwave ablation (MWA) followed by postprocedural MRI scan can be an alternative treatment for breast surgery in early stage breast cancer. Is the quality of life, the cosmetic outcome, fear of breast cancer recurrence, and costs in patient treated with MWA comparable or better compared to patients treated with breast surgery?

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • age should be 18 years and older
  • a solid non-lobular invasive breast tumor with a size <2cm based upon ultrasound and MRI measurements
  • without mammographic or MRI evidence of extensive disease
  • no involved lymph nodes on ultrasound and MRI scan.

排除标准

  • more than one breast tumor,
  • (lymph node) metastases
  • breast implants
  • indication for neoadjuvant chemotherapy.
  • pacemaker,
  • breastfeeding

结局指标

主要结局

MWA followed by MRI in breast tumors

时间窗: 1 year

MWA will be succesfull if less than 20% of the patients has residual disease

次要结局

  • breast cancer recurrence fear(Timepoints 4 days and 2 weeks after MWA and timepoints 4 days, 2 weeks and 2 months after surgery)
  • Quality of life(Timepoints 4 days and 2 weeks after MWA and timepoints 4 days, 2 weeks and 2 months after surgery)
  • Cosmetic outcome(Timepoints 4 days and 2 weeks after MWA and timepoints 4 days, 2 weeks and 2 months after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Monique Dorrius

Principal Investigator

University Medical Center Groningen

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