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 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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Cryoablation will be performed under ultrasound guidance.
Hcor
São Paulo, São Paulo, Brazil
Tumor ablation
Successful tumor ablation will be defined as absence of residual viable invasive or in situ carcinoma in the surgical specimen.
Time frame: 1 month
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.
Time frame: 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.
Time frame: 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.
Time frame: 14 days and 28 days
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