Clinical trial NCT02798796: Brazilian Randomized Study - Impact of MRI for Breast Cancer
Official title: Brazilian Randomized Study - Impact of Preoperative Magnetic Resonance in the Evaluation for Breast Cancer Conservative Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Keywords: breast cancer
conservative surgery
MRI
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2016-06-14
Enrollment: 372
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: False positive rate, false negative rate, positive predictive value and negative predictive value MRI in the Breast Cancer conservative surgery
timeFrame: 3 years
Secondary outcomes:
measure: Describe the percentage of positive margins on pathological examination
timeFrame: 3 years
measure: Describe the percentage of additional surgery rates
timeFrame: 3 years
measure: Describe the percentage surgical change from conservative surgery to mastectomy
timeFrame: 3 years
measure: 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
timeFrame: 3 years
measure: 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
timeFrame: 5 years
measure: Calculate how much is the cost to do the exam considering the false positive and false negative rates
timeFrame: 3 years
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Universidade de São Paulo
Study officials:
affiliation: University of Sao Paulo General Hospital
name: Bruna Salani Mota, Recruiting
role: PRINCIPAL_INVESTIGATOR
References: