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

NCT ID: NCT04561297

Last Updated: 2022-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-08
• Study Completion Date: 2021-12-31

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Biopsied Patients

Patients scheduled for a breast biopsy will have breast tissue dielectric constant measurements made prior to the biopsy

Group Type: EXPERIMENTAL

TDC differential value

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

TDC differential value

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Surgical Specialists of Miami

UNKNOWN

Sponsor Role: collaborator

Nova Southeastern University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Surgical Specialists of Miami

Aventura, Florida, United States

Countries

United States

Other Identifiers

2019-7-Non-NSU Health

Identifier Type: -

Identifier Source: org_study_id