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OpenTrials
Completed

NCT Number: NCT04561297

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Surgical Specialists of Miami

Aventura, Florida, 33180, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TDC differential value

Diagnostic Test

TDC measurements in all patients agreeing to participate who are scheduled for a biopsy of a breast tumor or mass

Primary outcomes

  1. TDC Tumor Differential

    Time frame: one hour

    Difference between TDC values measured at tumor site between benign vs. malignant

  2. TDC Inter-Breast Differentials

    Time frame: one hour

    Difference between TDC values measured at corresponding sites betweenbreasts

  3. TDC reference values for breasts

    Time frame: one hour

    Composite reference ranges for TDC values as measured on standard breast site of all

Sponsors and collaborators

Lead sponsor

Nova Southeastern University

Other

Collaborators

  • Surgical Specialists of Miami

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Sep 23, 2020
Registry last updated
Apr 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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