Clinical Trials Directory

Trials / Completed

CompletedNCT01859936

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

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

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
440 (actual)
Sponsor
Karolinska University Hospital · Academic / Other
Sex
All
Age
18 Years – 56 Years
Healthy volunteers
Not accepted

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)

Conditions

Interventions

TypeNameDescription
DEVICEMRIThe 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.

Timeline

Start date
2008-02-01
Primary completion
2011-02-01
Completion
2013-04-01
First posted
2013-05-22
Last updated
2013-05-29

Locations

1 site across 1 country: Sweden

Source: ClinicalTrials.gov record NCT01859936. Inclusion in this directory is not an endorsement.