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

Nova Southeastern University (NSU) logo

Nova Southeastern University (NSU)

Status

Completed

Conditions

Breast Cancer

Treatments

Diagnostic Test: TDC differential value

Study type

Interventional

Funder types

Other

Identifiers

NCT04561297
2019-7-Non-NSU Health

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

60 participants in 1 patient group

Biopsied Patients
Experimental group
Description:
Patients scheduled for a breast biopsy will have breast tissue dielectric constant measurements made prior to the biopsy
Treatment:
Diagnostic Test: TDC differential value

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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