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Completed

NCT Number: NCT03402997

Tissue Resistivity in Breast Cancer Patients

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

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Ospedale Regionale di Mendrisio

Mendrisio, 6850, Switzerland

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Resistivity measurement

Diagnostic Test

To measure and compare the tissue impedance values obtained by analysing ex vivo non-neoplastic (healthy and peritumoral) and neoplastic breast tissues

Primary outcomes

  1. Breat tissue characterization

    Time frame: 30 minutes from surgery

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

Secondary outcomes

  1. Evaluation of the precision of each EIS measurement

    Time frame: 30 minutes from surgery

    To evaluate the precision of each EIS measurement (healthy, peritumoral, cancerous) performed by the tissue impedance analyser in the same subject

  2. Correlation between electrical and biological results

    Time frame: 30 minutes from surgery

    To correlate the electrical behaviour of the breast cancer tissue to pathological and biological information

Sponsors and collaborators

Lead sponsor

Ente Ospedaliero Cantonale, Bellinzona

Other

Collaborators

  • Clinical Trial Unit Ente Ospedaliero Cantonale
  • Politecnico di Milano

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jan 18, 2018
Registry last updated
Dec 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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