Tissue Resistivity in Breast Cancer Patients

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

Detailed Description
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Diagnostic Test: Resistivity measurement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Resistivity measurements<br>The resistivity measurements will be done by introducing the needle-probe into fresh healthy, peritumoral, and tumoral ex vivo tissues | Diagnostic Test: Resistivity measurement<br>* To measure and compare the tissue impedance values obtained by analysing ex vivo non-neoplastic (healthy and peritumoral) and neoplastic breast tissues<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breat tissue characterization | Use of Electrical Impedance Spectroscopyuse (EIS) to characterize ex vivo non-neoplastic (healthy and peritumoral) and neoplastic breast tissues | 30 minutes from surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the precision of each EIS measurement | To evaluate the precision of each EIS measurement (healthy, peritumoral, cancerous) performed by the tissue impedance analyser in the same subject | 30 minutes from surgery | 
| Correlation between electrical and biological results | To correlate the electrical behaviour of the breast cancer tissue to pathological and biological information | 30 minutes from surgery |