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CompletedNCT03402997Updated Dec 12, 2019

Tissue Resistivity in Breast Cancer Patients

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

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
105
Ages
18 Years and older
Sex
Female
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Study summary

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

Read the 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.

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Conditions studied

  • Breast Cancer

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Sampling method
Probability sample

Study population

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.

Inclusion criteria

  • Age >18 years
  • First radiological diagnosis of breast adenocarcinoma needing a histological confirmation
  • Written Informed Consent

Exclusion criteria

Exclusion Criteria:

  • Tumor mass diameter \< 1 cm
  • Surgical specimen (harbouring tumoral + peritumoral tissue) diameter \< 2 cm
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
105 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

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

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What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

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Study locations

1 site
  • Ospedale Regionale di Mendrisio
    Mendrisio, 6850, Switzerland
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Registry details

Key details

Study ID
NCT03402997
Lead sponsor
Ente Ospedaliero Cantonale, Bellinzona
Collaborators
Politecnico di Milano, Clinical Trial Unit Ente Ospedaliero Cantonale
Responsible party
Sponsor
First posted
Jan 18, 2018
Start date
Dec 15, 2017
Primary completion
Sep 25, 2019
Completion
Sep 25, 2019
Last update
Dec 12, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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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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