An observational study in Breast Cancer, sponsored by Ente Ospedaliero Cantonale, Bellinzona. Completed at 1 site in Switzerland. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-12-12.
Sponsored by Ente Ospedaliero Cantonale, Bellinzona · Observational
The resistivity measurements will be done by introducing a needle-probe into fresh healthy, peritumoral, and tumoral ex vivo tissues.
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.
The target population of this study are female patients with first radiological diagnosis of breast cancer needing for surgery and subsequent histological examination to confirm the diagnosis.
Exclusion Criteria:
The resistivity measurements will be done by introducing the needle-probe into fresh healthy, peritumoral, and tumoral ex vivo tissues
Diagnostic Test: Resistivity measurement
To measure and compare the tissue impedance values obtained by analysing ex vivo non-neoplastic (healthy and peritumoral) and neoplastic breast tissues
Breat tissue characterization
Use of Electrical Impedance Spectroscopyuse (EIS) to characterize ex vivo non-neoplastic (healthy and peritumoral) and neoplastic breast tissues
Time frame: 30 minutes from surgery
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
Time frame: 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
Time frame: 30 minutes from surgery
Plan to share: Undecided
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This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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Ente Ospedaliero Cantonale, Bellinzona