- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03402997
Tissue Resistivity in Breast Cancer Patients
December 11, 2019 updated by: Ente Ospedaliero Cantonale, Bellinzona
Minimally Invasive Procedure for the Discrimination of Tissue Resistivity in Breast Cancer Patients
The resistivity measurements will be done by introducing a needle-probe into fresh healthy, peritumoral, and tumoral ex vivo tissues.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
105
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Mendrisio, Switzerland, 6850
- Ospedale Regionale di Mendrisio
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
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.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Resistivity measurements
The resistivity measurements will be done by introducing the needle-probe into fresh healthy, peritumoral, and tumoral ex vivo tissues
|
To measure and compare the tissue impedance values obtained by analysing ex vivo non-neoplastic (healthy and peritumoral) and neoplastic breast tissues
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Breat tissue characterization
Time Frame: 30 minutes from surgery
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Use of Electrical Impedance Spectroscopyuse (EIS) to characterize ex vivo non-neoplastic (healthy and peritumoral) and neoplastic breast tissues
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30 minutes from surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of the precision of each EIS measurement
Time Frame: 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
|
30 minutes from surgery
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Correlation between electrical and biological results
Time Frame: 30 minutes from surgery
|
To correlate the electrical behaviour of the breast cancer tissue to pathological and biological information
|
30 minutes from surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 15, 2017
Primary Completion (Actual)
September 25, 2019
Study Completion (Actual)
September 25, 2019
Study Registration Dates
First Submitted
January 11, 2018
First Submitted That Met QC Criteria
January 11, 2018
First Posted (Actual)
January 18, 2018
Study Record Updates
Last Update Posted (Actual)
December 12, 2019
Last Update Submitted That Met QC Criteria
December 11, 2019
Last Verified
December 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OBV-GASTRO-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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