Brazilian Randomized Study - Impact of MRI for Breast Cancer

Not Applicable

• Conditions: Breast Cancer
• Interventions: Device: MRI

• Registration Number: NCT02798796
• Lead Sponsor: University of Sao Paulo General Hospital

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.

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2015-08-03
• Status Verified: 2016-06
• Study First Submitted QC: 2016-06-08
• Last Update Submitted: 2016-06-08
• Study First Posted: 2016-06-14
• Last Update Posted: 2016-06-14
• Primary Completion: 2016-11
• Study Completion: 2016-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 372

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Describe the percentage of positive margins on pathological examination	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
Describe the percentage of additional surgery rates	3 years

Trial Locations

Locations (1)

Universidade de São Paulo; 🇧🇷 São Paulo, Brazil