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

Phase 4
Completed
Conditions
Breast Neoplasm
Interventions
Device: MRI
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)

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
Arm && Interventions
GroupInterventionDescription
preoperative breast MRIMRIThe intervention is that preoperative MRI breast will be performed in women under 56 years with newly diagnosed breast cancer
Primary Outcome Measures
NameTimeMethod
Change of treatment plan14 days

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

Secondary Outcome Measures
NameTimeMethod
Did breast magnetic resonance imaging reduce the number of reoperation during primary management6 months
Did breast magnetic resonance imaging increase the number of mastectomies6 months
Did breast magnetic resonance imaging affect cost6 months

Trial Locations

Locations (1)

Karolinska Univeristy Hospital

πŸ‡ΈπŸ‡ͺ

Stockholm, Sweden

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