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Tissue Resistivity in Breast Cancer Patients

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03402997
Enrollment
105
Registered
2018-01-18
Start date
2017-12-15
Completion date
2019-09-25
Last updated
2019-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

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.

Interventions

DIAGNOSTIC_TESTResistivity measurement

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

Sponsors

Politecnico di Milano
CollaboratorOTHER
Clinical Trial Unit Ente Ospedaliero Cantonale
CollaboratorOTHER
Ente Ospedaliero Cantonale, Bellinzona
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
Breat tissue characterization30 minutes from surgeryUse of Electrical Impedance Spectroscopyuse (EIS) to characterize ex vivo non-neoplastic (healthy and peritumoral) and neoplastic breast tissues

Secondary

MeasureTime frameDescription
Evaluation of the precision of each EIS measurement30 minutes from surgeryTo 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 results30 minutes from surgeryTo correlate the electrical behaviour of the breast cancer tissue to pathological and biological information

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026