Breast Cancer
Conditions
Keywords
breast cancer, conservative surgery, MRI
Brief summary
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.
Detailed description
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.
Interventions
DEVICEMRI
All patients will be submitted to MRI
Sponsors
University of Sao Paulo General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Female, * Over 18 years with breast cancer * Clinical stages I, II and III candidates for conservative surgery
Exclusion criteria
* Contra-indication for breast MRI (ex. Metal implant) * Claustrophobia * Impossibility to stay in the prone position for more than an hour * History of allergic reaction to the paramagnetic contrast * History of chronic kidney disease on dialysis * Personal history of breast cancer treated surgically in the last 12 months. * Pregnancy or breastfeeding past 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| False positive rate, false negative rate, positive predictive value and negative predictive value MRI in the Breast Cancer conservative surgery | 3 years |
Secondary
| Measure | Time frame |
|---|---|
| Describe the percentage of additional surgery rates | 3 years |
| Describe the percentage surgical change from conservative surgery to mastectomy | 3 years |
| Describe the percentage of positive margins on pathological examination | 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 |
| 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 |
Countries
Brazil
Contacts
Primary ContactBruna Salani Mota
Backup ContactMaíra Doria
Outcome results
None listed