Breast Cancer
Conditions
Keywords
tissue dielectric constant, breast cancer, tumor, biopsy
Brief summary
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
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.
Interventions
DIAGNOSTIC_TESTTDC differential value
TDC measurements in all patients agreeing to participate who are scheduled for a biopsy of a breast tumor or mass
Sponsors
Surgical Specialists of Miami
Nova Southeastern University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
Measurements are made prior to the biopsy determination of whether tumor is benign or malignant
Intervention model description
Patients scheduled for biopsy of the breast
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| TDC Tumor Differential | one hour | Difference between TDC values measured at tumor site between benign vs. malignant |
| TDC Inter-Breast Differentials | one hour | Difference between TDC values measured at corresponding sites betweenbreasts |
| TDC reference values for breasts | one hour | Composite reference ranges for TDC values as measured on standard breast site of all |
Countries
United States
Outcome results
None listed