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

June 8, 2016 updated by: University of Sao Paulo General Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

372

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
False positive rate, false negative rate, positive predictive value and negative predictive value MRI in the Breast Cancer conservative surgery
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Describe the percentage of positive margins on pathological examination
Time Frame: 3 years
3 years
Describe the percentage of additional surgery rates
Time Frame: 3 years
3 years
Describe the percentage surgical change from conservative surgery to mastectomy
Time Frame: 3 years
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
Time Frame: 3 years
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
Time Frame: 5 years
5 years
Calculate how much is the cost to do the exam considering the false positive and false negative rates
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Investigators

  • Principal Investigator: Bruna Salani Mota, Recruiting, University of Sao Paulo General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Anticipated)

November 1, 2016

Study Completion (Anticipated)

November 1, 2016

Study Registration Dates

First Submitted

August 3, 2015

First Submitted That Met QC Criteria

June 8, 2016

First Posted (Estimate)

June 14, 2016

Study Record Updates

Last Update Posted (Estimate)

June 14, 2016

Last Update Submitted That Met QC Criteria

June 8, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 974.504

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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