Tissue Resistivity in Breast Cancer Patients

Sponsor
Ente Ospedaliero Cantonale, Bellinzona (Other)
Overall Status
Completed
CT.gov ID
NCT03402997
Collaborator
Politecnico di Milano (Other), Clinical Trial Unit Ente Ospedaliero Cantonale (Other)
105
1
21.3
4.9

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Resistivity measurement

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 Design

Study Type:
Observational
Actual Enrollment :
105 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Minimally Invasive Procedure for the Discrimination of Tissue Resistivity in Breast Cancer Patients
Actual Study Start Date :
Dec 15, 2017
Actual Primary Completion Date :
Sep 25, 2019
Actual Study Completion Date :
Sep 25, 2019

Arms and Interventions

Arm Intervention/Treatment
Resistivity measurements

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

  2. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ospedale Regionale di Mendrisio Mendrisio Switzerland 6850

Sponsors and Collaborators

  • Ente Ospedaliero Cantonale, Bellinzona
  • Politecnico di Milano
  • Clinical Trial Unit Ente Ospedaliero Cantonale

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ente Ospedaliero Cantonale, Bellinzona
ClinicalTrials.gov Identifier:
NCT03402997
Other Study ID Numbers:
  • OBV-GASTRO-001
First Posted:
Jan 18, 2018
Last Update Posted:
Dec 12, 2019
Last Verified:
Dec 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 12, 2019