Assessing the Utility of Tissue Dielectric Constant (TDC) Measurements to Differentiate Breast Cancer From Healthy Breasts
Primary Purpose
Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TDC differential value
Sponsored by
About this trial
This is an interventional diagnostic trial for Breast Cancer focused on measuring tissue dielectric constant, breast cancer, tumor, biopsy
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
Sites / Locations
- Surgical Specialists of Miami
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Biopsied Patients
Arm Description
Patients scheduled for a breast biopsy will have breast tissue dielectric constant measurements made prior to the biopsy
Outcomes
Primary Outcome Measures
TDC Tumor Differential
Difference between TDC values measured at tumor site between benign vs. malignant
TDC Inter-Breast Differentials
Difference between TDC values measured at corresponding sites betweenbreasts
TDC reference values for breasts
Composite reference ranges for TDC values as measured on standard breast site of all
Secondary Outcome Measures
Full Information
NCT ID
NCT04561297
First Posted
September 17, 2020
Last Updated
April 13, 2022
Sponsor
Nova Southeastern University
Collaborators
Surgical Specialists of Miami
1. Study Identification
Unique Protocol Identification Number
NCT04561297
Brief Title
Assessing the Utility of Tissue Dielectric Constant (TDC) Measurements to Differentiate Breast Cancer From Healthy Breasts
Official Title
Assessing the Utility of Tissue Dielectric Constant (TDC) Measurements to Differentiate Breast Cancer From Healthy Breasts
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
February 8, 2019 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nova Southeastern University
Collaborators
Surgical Specialists of Miami
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
tissue dielectric constant, breast cancer, tumor, biopsy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Patients scheduled for biopsy of the breast
Masking
None (Open Label)
Masking Description
Measurements are made prior to the biopsy determination of whether tumor is benign or malignant
Allocation
N/A
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Biopsied Patients
Arm Type
Experimental
Arm Description
Patients scheduled for a breast biopsy will have breast tissue dielectric constant measurements made prior to the biopsy
Intervention Type
Diagnostic Test
Intervention Name(s)
TDC differential value
Intervention Description
TDC measurements in all patients agreeing to participate who are scheduled for a biopsy of a breast tumor or mass
Primary Outcome Measure Information:
Title
TDC Tumor Differential
Description
Difference between TDC values measured at tumor site between benign vs. malignant
Time Frame
one hour
Title
TDC Inter-Breast Differentials
Description
Difference between TDC values measured at corresponding sites betweenbreasts
Time Frame
one hour
Title
TDC reference values for breasts
Description
Composite reference ranges for TDC values as measured on standard breast site of all
Time Frame
one hour
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Must be scheduled for a breast biopsy with the collaborating centers
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Surgical Specialists of Miami
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Assessing the Utility of Tissue Dielectric Constant (TDC) Measurements to Differentiate Breast Cancer From Healthy Breasts
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