A handheld probe could flag breast tumors without a needle
NCT ID NCT04561297
First seen Oct 16, 2026 · Last updated Oct 16, 2026
Summary
Researchers are testing whether a non-invasive measurement called tissue dielectric constant (TDC) can tell breast cancer apart from healthy breast tissue. Participants scheduled for a breast biopsy have TDC measured at the tumor site, at a standard spot on the same breast, and at matching spots on the other breast before the biopsy. The team then compares those readings with the biopsy result to see whether a large TDC difference points to a malignant tumor. The goal is to learn whether TDC could one day help doctors decide who needs a biopsy.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- tissue dielectric constant (TDC) measurement, a non-invasive device test
- What this could lead to
- If the TDC differential reliably separates malignant from benign breast masses, it could offer a non-invasive way to help decide who needs a biopsy.
- What could go wrong
- This is a small diagnostic accuracy study, so it may not show a clear enough difference to replace or guide biopsy. TDC readings can also vary with skin moisture, age, and body composition.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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59 people
The number who actually took part.
- Started
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Feb 2019
- Finished
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Dec 2021
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Surgical Specialists of Miami
Aventura, Florida, 33180, United States
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