Percutaneous Cryoablation for the Treatment of Breast Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorOspedale Cottolengo
About this trial
The goal of this clinical trial is to study cryoablation as a treatment for selected adults with localized breast cancer. Cryoablation uses very low temperatures to destroy the tumor through thin needles placed through the skin under ultrasound guidance.
The main questions this study aims to answer are:
* Can cryoablation completely destroy the treated breast tumor? * Is the procedure safe and well tolerated? * Can ultrasound and contrast-enhanced mammography be used to monitor the treated area after cryoablation?
The study will include participants with breast cancer who cannot undergo surgery or choose not to have surgery, as well as selected postmenopausal participants with small, low-risk breast cancers.
Participants will undergo ultrasound-guided cryoablation instead of surgical removal of the breast tumor. They will then have clinical examinations and imaging follow-up, including ultrasound and contrast-enhanced mammography, to assess the treated area over time. A biopsy will be performed if follow-up findings are suspicious or unclear.
Other cancer treatments, such as radiation therapy or hormone therapy, will be given when indicated according to standard clinical practice.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Ultrasound-Guided Percutaneous Cryoablation
Procedure/SurgeryPercutaneous cryoablation of the primary breast tumor will be performed under local anesthesia and real-time ultrasound guidance. One or more cryoprobes will be positioned within the tumor according to lesion size and geometry. Freeze-thaw cycles will be performed to create an ice ball encompassing the tumor with an adequate safety margin, while protecting the skin and adjacent structures when necessary. Technical success and procedure-related adverse events will be recorded.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Ultrasound-Guided Percutaneous CryoablationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Complete Tumor Ablation at 6 Months
Proportion of participants with complete local tumor ablation at approximately 6 months after cryoablation. Complete ablation will be assessed by clinical examination, breast ultrasound, and contrast-enhanced mammography (CEM), with no evidence of residual viable tumor. Histologic confirmation by percutaneous biopsy will be performed only when clinical or imaging findings are suspicious or inconclusive.
Time frame
6 months after cryoablationSecondary outcomes
1
Technical Success of Cryoablation
Proportion of cryoablation procedures successfully completed according to the planned protocol, with adequate positioning of the cryoprobe and complete coverage of the target tumor by the ice ball, including the planned safety margin, as assessed by real-time ultrasound monitoring.
Time frame
During the cryoablation procedure2
Procedure-Related Adverse Events
Incidence and severity of adverse events related to the cryoablation procedure, including pain, bleeding, hematoma, infection, skin injury, and other procedure-related complications.
Time frame
From the cryoablation procedure through 30 days after treatment3
Residual or Recurrent Local Disease
Proportion of participants with imaging findings suggestive of residual or recurrent tumor at the treated site during follow-up. Assessment will be based on clinical examination, ultrasound, and contrast-enhanced mammography. Biopsy will be performed when imaging or clinical findings are suspicious or inconclusive.
Time frame
Up to 24 months after cryoablation4
Additional Local Treatment
Proportion of participants requiring additional local treatment of the treated breast tumor because of suspected or confirmed residual or recurrent disease, including repeat cryoablation or surgical treatment.
Time frame
Up to 24 months after cryoablationSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: