Brazilian Randomized Study - Impact of MRI for Breast Cancer

NCT ID: NCT02798796

Last Updated: 2016-06-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

372 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2016-11-30

Brief Summary

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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

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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MRI Group

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

Group Type EXPERIMENTAL

MRI

Intervention Type DEVICE

All patients will be submitted to MRI

Control Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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MRI

All patients will be submitted to MRI

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Sao Paulo General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bruna Salani Mota, Recruiting

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo General Hospital

Locations

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Universidade de São Paulo

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Bruna Salani Mota

Role: CONTACT

+55(11)976750200

Maíra Doria

Role: CONTACT

+55(11) 994494498

Facility Contacts

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Bruna Salani Mota

Role: primary

+55(11)976750200

Maira Doria

Role: backup

+55(11)994494498

Other Identifiers

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974.504

Identifier Type: -

Identifier Source: org_study_id

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