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临床试验/NCT03402997
NCT03402997已完成不适用

Minimally Invasive Procedure for the Discrimination of Tissue Resistivity in Breast Cancer Patients

Ente Ospedaliero Cantonale, Bellinzona1 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2017年12月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
105
试验地点
1
主要终点
Breat tissue characterization

研究概览

简要总结

The resistivity measurements will be done by introducing a needle-probe into fresh healthy, peritumoral, and tumoral ex vivo tissues.

详细描述

Patients affected by breast cancer will have their tissue analysed immediately following their surgical excision for the treatment of breast cancer. Two probes will be used: a linear probe of 4 needle-electrodes positioned in a row that is able to perform Electrical Impedance Spectroscopy (EIS) measurements and a circular probe of 8 needle-electrodes arranged into a circular pattern that is able to generate cross sectional images (Electrical Impedance Tomography maps). Firstly, the linear probe will be inserted in the tumor parenchyma at a penetration depth of about 2 mm and the tissue impedance measurement will be performed along a broad spectrum of frequencies for few minutes. Approximately 10 seconds for each measurement will be needed. Subsequently, if the size of the tissue will allow it, the circular probe will be inserted in the tumor parenchyma at the same penetration depth and 10 cross sectional maps will be generated (approximately 30 seconds in total). Both information obtained using the linear and the circular probes will be integrated for a full characterization of the tissue under examination.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

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 >18 years
  • First radiological diagnosis of breast adenocarcinoma needing a histological confirmation
  • Written Informed Consent

排除标准

  • Tumor mass diameter < 1 cm
  • Surgical specimen (harbouring tumoral + peritumoral tissue) diameter < 2 cm

结局指标

主要结局

Breat tissue characterization

时间窗: 30 minutes from surgery

Use of Electrical Impedance Spectroscopyuse (EIS) to characterize ex vivo non-neoplastic (healthy and peritumoral) and neoplastic breast tissues

次要结局

  • Evaluation of the precision of each EIS measurement(30 minutes from surgery)
  • Correlation between electrical and biological results(30 minutes from surgery)

研究者

发起方
Ente Ospedaliero Cantonale, Bellinzona
申办方类型
Other
责任方
Sponsor

研究点 (1)

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