Brazilian Randomized Study - Impact of MRI for Breast Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.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.

Official Title
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Brazilian Randomized Study - Impact of Preoperative Magnetic Resonance in the Evaluation for Breast Cancer Conservative Surgery

Conditions
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Breast Cancer

Intervention / Treatment
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* Device: MRI


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MRI Group<br>MRI Group - all patients will be submitted to clinical examination, mammography and / or ultrasound, and breast MRI | Device: MRI<br>* All patients will be submitted to MRI<br>|
| No Intervention: Control Group<br>Control group - all patients will be submitted to clinical examination, mammography and / or ultrasound of the breasts. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, conservative surgery, MRI