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

NCT04561297 | Completed FDA Device

• 1 other identifier: 2019-7-Non-NSU Health
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

tissue dielectric constant; breast cancer; tumor; biopsy

Outcome Measures

Primary Outcomes (3)

• TDC Tumor Differential

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

  one hour

• TDC Inter-Breast Differentials

  Difference between TDC values measured at corresponding sites betweenbreasts

  one hour

• TDC reference values for breasts

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

  one hour

Study Arms (1)

Biopsied Patients

EXPERIMENTAL

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

Diagnostic Test: TDC differential value

Interventions

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

Biopsied Patients

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Must be scheduled for a breast biopsy with the collaborating centers
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• You must be scheduled for a breast biopsy of a breast mass or abnormality with the collaborating centers

You may not qualify if:

• 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

Sponsors & Collaborators

• Nova Southeastern University: lead
• Surgical Specialists of Miami: collaborator

Study Sites (1)

Surgical Specialists of Miami

Aventura, Florida, 33180, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Measurements are made prior to the biopsy determination of whether tumor is benign or malignant
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients scheduled for biopsy of the breast

Study Record Dates

• First Submitted: September 17, 2020
• First Posted: September 23, 2020
• Study Start: February 8, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: April 14, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)