Breast CancerNCT04561297
Assessing Tissue Dielectric Constant (TDC) to Differentiate Breast Cancer Breast Cancer From Healthy Breasts
A study testing TDC differential value in people with Breast Cancer, run by Nova Southeastern University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- TDC differential value
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2019to 31 Dec 2021
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- You must be scheduled for a breast biopsy of a breast mass or abnormality with the collaborating centers
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Surgical Specialists of Miami
Aventura, Florida, 33180
About this study
Official title: Assessing the Utility of Tissue Dielectric Constant (TDC) Measurements to Differentiate Breast Cancer From Healthy Breasts
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- TDC differential value
- Keywords
- tissue dielectric constant, breast cancer, tumor, biopsy
- Medical subject headings
- Breast Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TDC differential valueDiagnostic test
TDC measurements in all patients agreeing to participate who are scheduled for a biopsy of a breast tumor or mass
| Study group | Role | What they receive |
|---|---|---|
| Biopsied Patients | Experimental | Patients scheduled for a breast biopsy will have breast tissue dielectric constant measurements made prior to the biopsy Receives: Diagnostic Test: TDC differential value |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tissue Dialectic Constant (TDC) Values
These are the measured TDC values on healthy breasts and on tumor bearing breasts. The tumors in the tumor bearing breasts could be diagnosed as benign or malignant. Differences between TDC values measured on the tumor breast and the contralateral normal breast constitute a TDC differential. Normally it is expected that the mean differential would be close to zero TDC units or 1% or less. If differences are large with the tumor site being greater then this would be an outcome that may help detect the presence of a malignant tumor.
Measured: one hour
Tissue Dielectric Constant (TDC) Reference Values for Breasts
Composite reference ranges for TDC values as measured on standard breast site of all
Measured: one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start8 Feb 2019
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients scheduled for biopsy of the breast
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Southeastern University
- Sponsor type
- University, hospital or other
- Collaborators
- Surgical Specialists of Miami
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04561297
- Sponsor's protocol ID
- 2019-7-Non-NSU Health
- Status last verified
- Oct 2026
- First submitted
- 17 Sep 2020
- Last updated
- 16 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No