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

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Diagnostic Test: TDC differential value

• Registration Number: NCT04561297
• Lead Sponsor: Nova Southeastern University

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.

Study Timeline

• Study Start: 2019-02-08
• Study First Submitted: 2020-09-17
• Study First Submitted QC: 2020-09-17
• Study First Posted: 2020-09-23
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-13
• Last Update Posted: 2022-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Biopsied Patients	TDC differential value	Patients scheduled for a breast biopsy will have breast tissue dielectric constant measurements made prior to the biopsy

Primary Outcome Measures

Name	Time	Method
TDC reference values for breasts	one hour	Composite reference ranges for TDC values as measured on standard breast site of all
TDC Inter-Breast Differentials	one hour	Difference between TDC values measured at corresponding sites betweenbreasts
TDC Tumor Differential	one hour	Difference between TDC values measured at tumor site between benign vs. malignant

Trial Locations

Locations (1)

Surgical Specialists of Miami; 🇺🇸 Aventura, Florida, United States