- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04561297
Assessing the Utility of Tissue Dielectric Constant (TDC) Measurements to Differentiate Breast Cancer From Healthy Breasts
April 13, 2022 updated by: Nova Southeastern University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Aventura, Florida, United States, 33180
- Surgical Specialists of Miami
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Biopsied Patients
Patients scheduled for a breast biopsy will have breast tissue dielectric constant measurements made prior to the biopsy
|
TDC measurements in all patients agreeing to participate who are scheduled for a biopsy of a breast tumor or mass
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
TDC Tumor Differential
Time Frame: one hour
|
Difference between TDC values measured at tumor site between benign vs. malignant
|
one hour
|
TDC Inter-Breast Differentials
Time Frame: one hour
|
Difference between TDC values measured at corresponding sites betweenbreasts
|
one hour
|
TDC reference values for breasts
Time Frame: one hour
|
Composite reference ranges for TDC values as measured on standard breast site of all
|
one hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 8, 2019
Primary Completion (Actual)
December 31, 2021
Study Completion (Actual)
December 31, 2021
Study Registration Dates
First Submitted
September 17, 2020
First Submitted That Met QC Criteria
September 17, 2020
First Posted (Actual)
September 23, 2020
Study Record Updates
Last Update Posted (Actual)
April 14, 2022
Last Update Submitted That Met QC Criteria
April 13, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-7-Non-NSU Health
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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