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The aim of this study is to evaluate the ability of MRI to select patients for conservative treatment of breast cancer. Participants: female, over 18 years with breast cancer, stages I, II and III candidates for conservative surgery will be randomly randomized to do MRI or not according mammary density.
The aim of this study is to evaluate the ability of MRI to select patients for conservative treatment of breast cancer.An accurate assessment of the tumor is essential to select the best therapeutic strategy in the treatment of breast cancer.Currently, mammography, ultrasound and clinical examination are the standard techniques to assess the extent and location of the tumor.However, these imaging methods fail to assess the real size in approximately one third of patients eligible to conservative treatment.MRI has high sensitivity (95-100%) in the detection of invasive cancers as well as being able to detect hidden tumors, multifocality, multicentricity and cancer in the contralateral breast more often and greater accuracy than mammography or ultrasound.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MRI Group | Experimental | MRI Group - all patients will be submitted to clinical examination, mammography and / or ultrasound, and breast MRI |
|
| Control Group | No Intervention | Control group - all patients will be submitted to clinical examination, mammography and / or ultrasound of the breasts. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI | Device | All patients will be submitted to MRI |
|
| Measure | Description | Time Frame |
|---|---|---|
| False positive rate, false negative rate, positive predictive value and negative predictive value MRI in the Breast Cancer conservative surgery | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Describe the percentage of positive margins on pathological examination | 3 years | |
| Describe the percentage of additional surgery rates | 3 years | |
| Describe the percentage surgical change from conservative surgery to mastectomy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bruna Salani Mota | Contact | +55(11)976750200 | brunasalani@hotmail.com | |
| MaÃra Doria | Contact | +55(11) 994494498 | maira_doria@yahoo.com.br |
| Name | Affiliation | Role |
|---|---|---|
| Bruna Salani Mota, Recruiting | University of Sao Paulo General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidade de São Paulo | Recruiting | São Paulo | São Paulo | 01246903 | Brazil |
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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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| 3 years |
| Calculate the False positive rate, false negative rate , positive predictive value and negative predictive value according mammographic density, molecular subtype and histopathology of the tumor | 3 years |
| Calculate the period after successful treatment in which there is no appearance of the symptoms or effects of the disease after 3 and 5 years bettwen groups | 5 years |
| Calculate how much is the cost to do the exam considering the false positive and false negative rates | 3 years |
| D017437 |
| Skin and Connective Tissue Diseases |