Breast Cancer, Breast Neoplasms
Conditions
Keywords
cryoablation, cryotherapy, breast cancer
Brief summary
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.
Detailed description
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 1. Core biopsy 2. Mammogram 3. Magnetic resonance imaging 4. Ultrasound 5. Tumor Cryoablation 6. Mammogram (post-cryoablation) 7. Magnetic resonance imaging (post-cryoablation) 8. Ultrasound (post-cryoablation) 9. Surgery 10. Evaluation of outcomes
Interventions
DEVICECryoablation
Cryoablation will be performed under ultrasound guidance.
Sponsors
Hospital do Coracao
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Unifocal primary invasive breast carcinoma * Pathological report should be complete (with the result of ER, PR , HER2, KI67 and FISH report of ERBB2 gene if necessary) * Maximum tumor size ≤2.5 cm in its greatest diameter * Ultrasound visible lesion
Exclusion criteria
* Multifocal or multicentric invasive breast carcinoma * Ductal carcinoma in-situ * Breast cancer with skin involvement * Clinically positive axilla (N1, N2 or N3) * Distance from lesion and skin less than 5 mm * Prior neoadjuvant systemic therapy for breast cancer * Distant metastasis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tumor ablation | 1 month | Successful tumor ablation will be defined as absence of residual viable invasive or in situ carcinoma in the surgical specimen. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Negative predictive value of magnetic resonance imaging (MRI) | 14 days and 28 days | 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. |
| Accuracy of conventional imaging methods (mammography and ultrasound) | 14 days and 28 days | 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. |
| Measurement of the ice ball by ultrasound | 14 days and 28 days | To compare the baseline tumor size, ultrasound measurement of the ice ball, and the pathological result. |
Countries
Brazil
Contacts
Primary ContactVanessa M Sanvido, PhD
Backup ContactAfonso P Nazário, Professor
Outcome results
None listed