Breast CancerCRYSTALNCT07775014
Percutaneous Cryoablation for the Treatment of Breast Cancer
A study testing Ultrasound-Guided Percutaneous Cryoablation in people with Breast Cancer and Breast Cancer - Infiltrating Ductal Carcinoma, run by Ospedale Cottolengo at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Breast Cancer - Infiltrating Ductal Carcinoma
- What is being tested?
- Ultrasound-Guided Percutaneous Cryoablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2026to Nov 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 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.
Show all 18Show fewer
- 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
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Ospedale Cottolengo
Torino, TO, 10152
EUGENIO ZANON, 3284721090, eugenio.zanon@gmail.com
About this study
Official title: Percutaneous Cryoablation for the Treatment of Breast Cancer: A Prospective Study of Clinical Effectiveness, Safety, and CEM-Based Imaging Surveillance
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:
Read more
- 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.
Read the detailed description
CRYSTAL is a prospective, single-center, single-arm interventional study evaluating ultrasound-guided percutaneous cryoablation for the treatment of selected patients with localized breast cancer.
The study includes two clinical cohorts. Cohort A includes patients with localized breast cancer who are not suitable candidates for surgery because of age, comorbidities, or other clinical factors, as well as patients who decline surgery after appropriate multidisciplinary evaluation and counseling. Cohort B includes selected postmenopausal patients with small, unifocal, biologically low-risk breast cancers considered suitable for a minimally invasive treatment strategy.
All participants will have histologically confirmed breast cancer before treatment, with assessment of relevant prognostic and predictive tumor markers. Eligibility and treatment strategy will be discussed within the multidisciplinary breast unit.
Cryoablation will be performed percutaneously under ultrasound guidance. The procedure will aim to obtain complete coverage of the tumor by the ice ball with an appropriate safety margin while protecting the skin, chest wall, and other adjacent structures.
Participants will undergo clinical and imaging surveillance after treatment. Ultrasound and contrast-enhanced mammography (CEM) will be the principal imaging techniques used to assess the ablation area and detect possible residual or recurrent disease. Breast magnetic resonance imaging may be used when CEM is contraindicated, not feasible, or inconclusive. Tissue sampling will be performed when clinical or imaging findings are suspicious or inconclusive.
The primary objective is to evaluate complete local tumor ablation approximately 6 months after cryoablation. Secondary objectives include technical success, procedure-related adverse events, residual disease, need for repeat cryoablation or subsequent surgery, procedural characteristics, quality of life, and local recurrence during follow-up.
Adjuvant systemic treatment and/or radiation therapy will be administered when clinically indicated according to multidisciplinary assessment and standard clinical practice. Participants will be followed for up to 24 months after cryoablation.
- Being tested
- Ultrasound-Guided Percutaneous Cryoablation
- Keywords
- Breast Cryoablation, Percutaneous Cryoablation, Minimally Invasive Treatment, Contrast-Enhanced Mammography, Early Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-Guided Percutaneous CryoablationProcedure or surgery
Percutaneous 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.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound-Guided Percutaneous Cryoablation | Experimental | Participants with localized breast cancer will undergo ultrasound-guided percutaneous cryoablation of the primary breast tumor. Treatment will be performed under local anesthesia with real-time ultrasound monitoring of the ice ball. Participants will subsequently undergo clinical and imaging follow-up according to the study protocol. Receives: Procedure: Ultrasound-Guided Percutaneous Cryoablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months after cryoablation
Secondary outcomes (6)
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.
Measured: During the cryoablation procedure
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.
Measured: From the cryoablation procedure through 30 days after treatment
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.
Measured: Up to 24 months after cryoablation
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.
Measured: Up to 24 months after cryoablation
Cryoablation Procedure Duration
Duration of the cryoablation procedure, measured from the start of cryoprobe placement to completion of cryoprobe removal.
Measured: During the cryoablation procedure
Ablation Margin
Minimum distance between the tumor boundary and the outer margin of the ice ball during cryoablation, as measured by real-time ultrasound. The measurement will be recorded in millimeters.
Measured: During the cryoablation procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study startNov 2026 (estimated)
- Primary completionMay 2029 (estimated)
- Study completionNov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ospedale Cottolengo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- EUGENIO ZANON, MD, Principal investigator, Ospedale Cottolengo - Breast Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07775014
- Sponsor's protocol ID
- COTT-CRYO-01
- Acronym
- CRYSTAL
- Status last verified
- Aug 2026
- First submitted
- 15 Aug 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared outside the study research team. Study results may be shared or published only in aggregated form.
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Cryoablation for the Treatment of Breast Cancer: A Prospective Study of Clinical Effectiveness, Safety, and CEM-Based Imaging Surveillance
- ClinicalTrials.gov ID
- NCT07775014
- Acronym / sponsor ID
- CRYSTAL / COTT-CRYO-01
- Keywords
- Breast Cryoablation, Percutaneous Cryoablation, Minimally Invasive Treatment, Contrast-Enhanced Mammography, Early Breast Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ospedale CottolengoUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- May 2029 (estimated)
- Study completion
- Nov 2030 (estimated)
- First posted
- 19 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
CRYSTAL is a prospective, single-center, single-arm interventional study evaluating ultrasound-guided percutaneous cryoablation for the treatment of selected patients with localized breast cancer.
The study includes two clinical cohorts. Cohort A includes patients with localized breast cancer who are not suitable candidates for surgery because of age, comorbidities, or other clinical factors, as well as patients who decline surgery after appropriate multidisciplinary evaluation and counseling. Cohort B includes selected postmenopausal patients with small, unifocal, biologically low-risk breast cancers considered suitable for a minimally invasive treatment strategy.
All participants will have histologically confirmed breast cancer before treatment, with assessment of relevant prognostic and predictive tumor markers. Eligibility and treatment strategy will be discussed within the multidisciplinary breast unit.
Cryoablation will be performed percutaneously under ultrasound guidance. The procedure will aim to obtain complete coverage of the tumor by the ice ball with an appropriate safety margin while protecting the skin, chest wall, and other adjacent structures.
Participants will undergo clinical and imaging surveillance after treatment. Ultrasound and contrast-enhanced mammography (CEM) will be the principal imaging techniques used to assess the ablation area and detect possible residual or recurrent disease. Breast magnetic resonance imaging may be used when CEM is contraindicated, not feasible, or inconclusive. Tissue sampling will be performed when clinical or imaging findings are suspicious or inconclusive.
The primary objective is to evaluate complete local tumor ablation approximately 6 months after cryoablation. Secondary objectives include technical success, procedure-related adverse events, residual disease, need for repeat cryoablation or subsequent surgery, procedural characteristics, quality of life, and local recurrence during follow-up.
Adjuvant systemic treatment and/or radiation therapy will be administered when clinically indicated according to multidisciplinary assessment and standard clinical practice. Participants will be followed for up to 24 months after cryoablation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultrasound-Guided Percutaneous Cryoablation | Experimental | Procedure: Ultrasound-Guided Percutaneous CryoablationParticipants with localized breast cancer will undergo ultrasound-guided percutaneous cryoablation of the primary breast tumor. Treatment will be performed under local anesthesia with real-time ultrasound monitoring of the ice ball. Participants will subsequently undergo clinical and imaging follow-up according to the study protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound-Guided Percutaneous CryoablationPercutaneous 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. | Procedure or surgery | Ultrasound-Guided Percutaneous Cryoablation |
Primary outcome
Complete Tumor Ablation at 6 Months
Time frame: 6 months after cryoablation
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.
6 secondary outcomes
Technical Success of Cryoablation
Time frame: During the cryoablation procedure
Procedure-Related Adverse Events
Time frame: From the cryoablation procedure through 30 days after treatment
Residual or Recurrent Local Disease
Time frame: Up to 24 months after cryoablation
Additional Local Treatment
Time frame: Up to 24 months after cryoablation
Cryoablation Procedure Duration
Time frame: During the cryoablation procedure
Ablation Margin
Time frame: During the cryoablation procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared outside the study research team. Study results may be shared or published only in aggregated form.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
EUGENIO ZANON, MD principal investigator
Ospedale Cottolengo - Breast Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-Guided Percutaneous Cryoablation in people with Breast Cancer and Breast Cancer - Infiltrating Ductal Carcinoma, run by Ospedale Cottolengo at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact EUGENIO ZANON, MD (39 3284721090, eugenio.zanon@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Tumor Ablation at 6 Months (time frame: 6 months after cryoablation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.