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

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
MRI
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Cancer focused on measuring breast cancer, conservative surgery, MRI

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts 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

Sites / Locations

  • Universidade de São PauloRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

MRI Group

Control Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

False positive rate, false negative rate, positive predictive value and negative predictive value MRI in the Breast Cancer conservative surgery

Secondary Outcome Measures

Describe the percentage of positive margins on pathological examination
Describe the percentage of additional surgery rates
Describe the percentage surgical change from conservative surgery to mastectomy
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
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
Calculate how much is the cost to do the exam considering the false positive and false negative rates

Full Information

First Posted
August 3, 2015
Last Updated
June 8, 2016
Sponsor
University of Sao Paulo General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02798796
Brief Title
Brazilian Randomized Study - Impact of MRI for Breast Cancer
Acronym
BREAST-MRI
Official Title
Brazilian Randomized Study - Impact of Preoperative Magnetic Resonance in the Evaluation for Breast Cancer Conservative Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2014 (undefined)
Primary Completion Date
November 2016 (Anticipated)
Study Completion Date
November 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
breast cancer, conservative surgery, MRI

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
372 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MRI Group
Arm Type
Experimental
Arm Description
MRI Group - all patients will be submitted to clinical examination, mammography and / or ultrasound, and breast MRI
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Control group - all patients will be submitted to clinical examination, mammography and / or ultrasound of the breasts.
Intervention Type
Device
Intervention Name(s)
MRI
Intervention Description
All patients will be submitted to MRI
Primary Outcome Measure Information:
Title
False positive rate, false negative rate, positive predictive value and negative predictive value MRI in the Breast Cancer conservative surgery
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Describe the percentage of positive margins on pathological examination
Time Frame
3 years
Title
Describe the percentage of additional surgery rates
Time Frame
3 years
Title
Describe the percentage surgical change from conservative surgery to mastectomy
Time Frame
3 years
Title
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
Title
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
Title
Calculate how much is the cost to do the exam considering the false positive and false negative rates
Time Frame
3 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bruna Salani Mota
Phone
+55(11)976750200
Email
brunasalani@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Maíra Doria
Phone
+55(11) 994494498
Email
maira_doria@yahoo.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruna Salani Mota, Recruiting
Organizational Affiliation
University of Sao Paulo General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidade de São Paulo
City
São Paulo
ZIP/Postal Code
01246903
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bruna Salani Mota
Phone
+55(11)976750200
Email
brunasalani@hotmail.com
First Name & Middle Initial & Last Name & Degree
Maira Doria
Phone
+55(11)994494498
Email
maira_doria@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Brazilian Randomized Study - Impact of MRI for Breast Cancer

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