Tissue Resistivity in Breast Cancer Patients

Completed

• Conditions: Breast Cancer
• Interventions: Diagnostic Test: Resistivity measurement

• Registration Number: NCT03402997
• Lead Sponsor: Ente Ospedaliero Cantonale, Bellinzona

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2017-12-15
• Study First Submitted: 2018-01-11
• Study First Submitted QC: 2018-01-11
• Study First Posted: 2018-01-18
• Primary Completion: 2019-09-25
• Study Completion: 2019-09-25
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-11
• Last Update Posted: 2019-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 105

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Resistivity measurements	Resistivity measurement	The resistivity measurements will be done by introducing the needle-probe into fresh healthy, peritumoral, and tumoral ex vivo tissues

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Evaluation of the precision of each EIS measurement	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
Correlation between electrical and biological results	30 minutes from surgery	To correlate the electrical behaviour of the breast cancer tissue to pathological and biological information

Trial Locations

Locations (1)

Ospedale Regionale di Mendrisio; 🇨🇭 Mendrisio, Switzerland