NCT02798796

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
372

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Nov 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2015

Completed
11 months until next milestone

First Posted

Study publicly available on registry

June 14, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

June 14, 2016

Status Verified

June 1, 2016

Enrollment Period

2 years

First QC Date

August 3, 2015

Last Update Submit

June 8, 2016

Conditions

Breast Cancer

Keywords

breast cancerconservative surgeryMRI

Outcome Measures

Primary Outcomes (1)

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

    3 years

Secondary Outcomes (6)

  • Describe the percentage of positive margins on pathological examination

    3 years

  • Describe the percentage of additional surgery rates

    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

  • +1 more secondary outcomes

Study Arms (2)

MRI Group

EXPERIMENTAL

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

Device: MRI

Control Group

NO INTERVENTION

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

Interventions

MRIDEVICE

All patients will be submitted to MRI

MRI Group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female,
  • Over 18 years with breast cancer
  • Clinical stages I, II and III candidates for conservative surgery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade de São Paulo

São Paulo, São Paulo, 01246903, Brazil

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Bruna Salani Mota, Recruiting

    University of Sao Paulo General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bruna Salani Mota

CONTACT

+55(11)976750200brunasalani@hotmail.com

Maíra Doria

CONTACT

+55(11) 994494498maira_doria@yahoo.com.br

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2015

First Posted

June 14, 2016

Study Start

November 1, 2014

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

June 14, 2016

Record last verified: 2016-06

Locations

BR(1)