Brazilian Randomized Study - Impact of MRI for Breast Cancer (BREAST-MRI)

University of Sao Paulo General Hospital

Status: Unknown

Conditions: Breast Cancer

Treatments: Device: MRI

Study type: Interventional

Funder types: Other

Identifiers

NCT02798796

974.504

Details and patient eligibility

About

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.

Full 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.

Enrollment: 372 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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372 participants in 2 patient groups

MRI Group

Experimental group

Description:

MRI Group - all patients will be submitted to clinical examination, mammography and / or ultrasound, and breast MRI

Treatment:

Device: MRI

Control Group

No Intervention group

Description:

Control group - all patients will be submitted to clinical examination, mammography and / or ultrasound of the breasts.