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Tissue Resistivity in Breast Cancer Patients

NCT ID: NCT03402997

Last Updated: 2019-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

105 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-15

Study Completion Date

2019-09-25

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.

Conditions

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Breast Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Resistivity measurements

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

Resistivity measurement

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Resistivity measurement

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

Intervention Type DIAGNOSTIC_TEST

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Politecnico di Milano

OTHER

Sponsor Role collaborator

Clinical Trial Unit Ente Ospedaliero Cantonale

OTHER

Sponsor Role collaborator

Ente Ospedaliero Cantonale, Bellinzona

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ospedale Regionale di Mendrisio

Mendrisio, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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OBV-GASTRO-001

Identifier Type: -

Identifier Source: org_study_id