Randomized Multicenter Trial Assessing if Preoperative MRI Breast in Women Under 56 Years With Breast Cancer Will Change Primary Treatment

Karolinska University Hospital1 site in 1 country440 target enrollmentFebruary 2008

ConditionsBreast Neoplasm

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Breast Neoplasm
Sponsor: Karolinska University Hospital
Enrollment: 440
Locations: 1
Primary Endpoint: Change of treatment plan
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The study is a prospective randomised multicenter trial assessing the additional value of breast MRI in women under 56 years of age with newly diagnosed breast cancer. Will preoperative breast MRI change treatment regimen? Will preoperative breast MRI reduce the number of primary surgeries? Will preoperative breast MRI increase the rate of mastectomies? Will preoperative breast MRI be cost effective?

Detailed Description

Completed: the study has concluded normally; participants are no longer being examined or treated (i.e., last patient's last visit has occurred)

Registry

clinicaltrials.gov

Start Date

February 2008

End Date

April 2013

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Karolinska University Hospital

Responsible Party

Principal Investigator

Brita Arver

MD, PhD

Karolinska University Hospital

Eligibility Criteria

Inclusion Criteria

•Women under 56 years of age
•Newly diagnosed breast cancer
•Swedish or English speaking

Exclusion Criteria

•Claustrophobia
•Pregnancy
•Renal failure
•Metal items in patients

Outcomes

Primary Outcomes

Change of treatment plan

Time Frame: 14 days

Did breast magnetic resonance imaging add information about the tumour that changed primary treatment plan

Secondary Outcomes

Did breast magnetic resonance imaging reduce the number of reoperation during primary management(6 months)
Did breast magnetic resonance imaging increase the number of mastectomies(6 months)
Did breast magnetic resonance imaging affect cost(6 months)