Assessing the Utility of Tissue Dielectric Constant (TDC) Measurements to Differentiate Breast Cancer From Healthy Breasts

Study Overview
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Brief Summary
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Patients with pending breast biopsies will have the tumor site's tissue dielectric constant (TDC) measured prior to the biopsy. Similar TDC measurements will be made at a standard breast site on the biopsied breast and on mirrored sites on the non-affected breast.

Detailed Description
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Patients with pending breast biopsies will have the tumor site's tissue dielectric constant (TDC) measured prior to the biopsy. Similar TDC measurements will be made at a standard breast site on the biopsied breast and on mirrored sites on the non-affected breast. Values obtained at the biopsy site will be compared against the outcome of the biopsy analysis: benign vs. malignant. In addition the measurements obtained at the standardized site for all breasts will be used to establish a set of reference values to characterize breast TDC values. In addition, inter-breast differentials will be used to characterize these ranges for future studies and clinical assessments.

Official Title
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Assessing the Utility of Tissue Dielectric Constant (TDC) Measurements to Differentiate Breast Cancer From Healthy Breasts

Conditions
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Breast Cancer

Intervention / Treatment
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* Diagnostic Test: TDC differential value


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: You must be scheduled for a breast biopsy of a breast mass or abnormality with the collaborating centers Exclusion Criteria: You have any open wounds over the breasts You have had breast cancer You have or have had breast implants or have undergone any breast surgery or breast biopsy You have any implantable wires, this includes a Pacemaker, Implantable Cardioverter ° Defibrillators (ICDs), and/or Left Ventricular Assist Device (LVAD) You are pregnant

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Patients scheduled for biopsy of the breast
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Biopsied Patients<br>Patients scheduled for a breast biopsy will have breast tissue dielectric constant measurements made prior to the biopsy | Diagnostic Test: TDC differential value<br>* TDC measurements in all patients agreeing to participate who are scheduled for a biopsy of a breast tumor or mass<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TDC Tumor Differential | Difference between TDC values measured at tumor site between benign vs. malignant | one hour | 
| TDC Inter-Breast Differentials | Difference between TDC values measured at corresponding sites betweenbreasts | one hour | 
| TDC reference values for breasts | Composite reference ranges for TDC values as measured on standard breast site of all | one hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tissue dielectric constant, breast cancer, tumor, biopsy