Can freezing breast tumors replace the scalpel?
NCT ID NCT07775014
First seen Aug 19, 2026 · Last updated Aug 20, 2026 · Updated 1 time
Summary
This trial is investigating whether cryoablation, a technique that freezes and destroys breast tumors with extreme cold, can be an effective alternative to surgery for certain patients. The study will include adults with localized breast cancer who cannot or choose not to have surgery, as well as some postmenopausal women with small, low-risk tumors. Participants will receive ultrasound-guided cryoablation and then be monitored with imaging to see if the tumor is completely destroyed and if the procedure is safe.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Percutaneous cryoablation, a procedure that uses extreme cold to freeze and destroy breast tumors through thin needles guided by ultrasound.
- What this could lead to
- If successful, this could offer a non-surgical treatment option for certain breast cancer patients, potentially reducing the need for surgery and its associated recovery.
- What could go wrong
- This is a small, early-stage study, so results may not apply to all patients. There is a risk the tumor may not be completely destroyed, and follow-up imaging may not reliably detect residual disease.
This is an AI summary of the original study and may miss details. Read our disclaimer.
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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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Nov 2026
An estimate. Start dates often move.
- Expected to finish
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Nov 2030
An estimate. End dates often move.
- 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: General criteria: * Female participants aged 18 years or older. * Histologically confirmed invasive breast carcinoma diagnosed by core needle biopsy. * Unifocal and unilateral tumor. * Tumor clearly visible and accessible by ultrasound. * Tumor considered technically suitable for ultrasound-guided cryoablation, with the possibility of achieving adequate ice-ball coverage and safety margins. * No known distant metastatic disease. * Ability to understand the study procedures and provide written informed consent. Cohort A: \- Participants considered unsuitable for breast surgery because of age, comorbidities, or other clinical conditions, or participants who decline surgical treatment after appropriate multidisciplinary evaluation. Cohort B: * Postmenopausal participants with early-stage, low-risk invasive breast cancer. * Invasive tumor preferably 15 mm or smaller. * Hormone receptor-positive (estrogen receptor and/or progesterone receptor positive). * HER2-negative. * Histological grade 1 or 2. * Clinically node-negative disease. * Invasive carcinoma of no special type or another favorable low-risk histological subtype Exclusion Criteria: * Multifocal or multicentric breast cancer. * Bilateral breast cancer requiring treatment. * Tumor not adequately visible or accessible by ultrasound. * Tumor location or anatomy preventing safe cryoablation or achievement of an adequate ablation margin. * Known distant metastatic disease. * HER2-positive invasive breast cancer for Cohort B. * Predominantly extensive intraductal disease or other findings considered unsuitable for cryoablation. * Contraindication to the planned cryoablation procedure. * Inability to provide informed consent or comply with study follow-up.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Ospedale Cottolengo
Torino, TO, 10152, Italy
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