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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04561297
• Other study ID #: 2019-7-Non-NSU Health
• Status: Completed
• Phase: N/A
• Start date: February 8, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: April 2022
• Source: Nova Southeastern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Diagnostic Test:
• TDC differential value
TDC measurements in all patients agreeing to participate who are scheduled for a biopsy of a breast tumor or mass

Locations

Country	Name	City	State
United States	Surgical Specialists of Miami	Aventura	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Nova Southeastern University	Surgical Specialists of Miami

Country where clinical trial is conducted

United States, 

Outcome

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