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Image-guided tumor ablation is a non-surgical, minimally invasive therapy available for local therapy of some carcinomas as an alternative to surgical treatment. This study assesses whether cryoablation can be used as an alternative to surgery in cases of early invasive breast carcinoma.
Purpose: To evaluate the effectiveness of cryoablation in the local treatment of breast cancer, through the absence of neoplastic cells (invasive or in situ).
Outline
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early stage breast cancer up to 2.5 cm | Experimental | Patients treated with Cryocare SL followed by traditional surgery, radiotherapy and adjuvant systemic therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cryoablation | Device | Cryoablation will be performed under ultrasound guidance. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tumor ablation | Successful tumor ablation will be defined as absence of residual viable invasive or in situ carcinoma in the surgical specimen. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Negative predictive value of magnetic resonance imaging (MRI) | Magnetic resonance imaging will be conducted between 14 to 28 days after cryoablation. Negative predictive value of MRI will be calculated according to the pathological report after the traditional surgery. Negative predictive value = number of the patients who is pathologically negative divided by the number of patients who is MRI negative. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vanessa M Sanvido, PhD | Contact | 551138864688 | dravanessasanvido@gmail.com | |
| Afonso P Nazário, Professor | Contact | nazarioafonso@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Alexandre B Cavalcanti, PhD | Hospital do Coracao | Study Director |
| Bruna MP Vianna | Hospital do Coracao | Principal Investigator |
| Vanessa M Sanvido, PhD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hcor | São Paulo | São Paulo | 04004-030 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42157305 | Derived | Sanvido VM, Bromberg SE, Waitzberg AFL, Gomes JO, Barbante LG, Socolowski LR, Tachibana BMT, Junior AR, Miranda TA, Negrelli KDL, Martins EVDN, Santos RHN, Vianna PM, da Silva LM, Cavalcanti AB, Nazario ACP. Cryoablation for early-stage invasive breast cancer: pathologic and imaging outcomes from the prospective FIRST trial. Breast Cancer Res. 2026 May 19. doi: 10.1186/s13058-026-02302-y. Online ahead of print. |
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There is a plan to share IPD in the article publication.
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D003452 | Cryosurgery |
| ID | Term |
|---|---|
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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| 14 days and 28 days |
| Accuracy of conventional imaging methods (mammography and ultrasound) | Mammography and ultrasound will be conducted between 14 to 28 days after cryoablation. Accuracy of conventional imaging methods will be calculated according to the pathological report after the traditional surgery. | 14 days and 28 days |
| Measurement of the ice ball by ultrasound | To compare the baseline tumor size, ultrasound measurement of the ice ball, and the pathological result. | 14 days and 28 days |
| Hospital do Coracao |
| Principal Investigator |
| Afonso CP Nazário, Professor | Hospital do Coracao | Principal Investigator |
| D017437 |
| Skin and Connective Tissue Diseases |