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

NCT01859936 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 440

Last updated 2013-05-29

No results posted yet for this study

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?

Conditions

  • Breast Neoplasm

Interventions

DEVICE

MRI

The intervention is that preoperative MRI breast will be performed in 220 women under 56 years with newly diagnosed breast cancer. Aims are to analyze if the intervention will affect primary management, decrease the number of reoperations and to analyze if the intervention leads to an increasing number of unnecessary mastectomies compared to the non intervention arm.

Sponsors & Collaborators

  • Karolinska Institutet

    collaborator OTHER

  • Uppsala University Hospital

    collaborator OTHER

  • Karolinska University Hospital

    lead OTHER

Principal Investigators

  • Brita Arver, MD PhD · Karolinska University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
56 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2011-02-28
Completion
2013-04-30

Countries

  • Sweden

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01859936 on ClinicalTrials.gov