Will Preoperative MRI Breast in Women Under 56 Years With Breast Cancer Change Primary Treatment

Phase 4

Completed

• Conditions: Breast Neoplasm

• Registration Number: NCT01859936
• Lead Sponsor: Karolinska University Hospital

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)

Study Timeline

• Study Start: 2008-02
• Primary Completion: 2011-02
• Study Completion: 2013-04
• Status Verified: 2013-05
• Study First Submitted: 2013-05-16
• Study First Submitted QC: 2013-05-19
• Study First Posted: 2013-05-22
• Last Update Submitted: 2013-05-27
• Last Update Posted: 2013-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 440

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change of treatment plan	14 days	Did breast magnetic resonance imaging add information about the tumour that changed primary treatment plan

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Karolinska Univeristy Hospital; 🇸🇪 Stockholm, Sweden