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

May 27, 2013 updated by: Brita Arver, Karolinska University Hospital

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

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?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

440

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 17176
        • Karolinska Univeristy Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 56 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: preoperative breast MRI
The intervention is that preoperative MRI breast will be performed in women under 56 years with newly diagnosed breast cancer
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.
No Intervention: no MRI breast
The arm type description implies that no MRI breast will be performed to women under 56 years with newly diagnosed breast cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of treatment plan
Time Frame: 14 days
Did breast magnetic resonance imaging add information about the tumour that changed primary treatment plan
14 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Did breast magnetic resonance imaging reduce the number of reoperation during primary management
Time Frame: 6 months
6 months
Did breast magnetic resonance imaging increase the number of mastectomies
Time Frame: 6 months
6 months
Did breast magnetic resonance imaging affect cost
Time Frame: 6 months
6 months

Other Outcome Measures

Outcome Measure
Time Frame
Is the sensitivity of breast MRI dependant on density and/or on age
Time Frame: 14 days
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska University Hospital

Collaborators

Karolinska Institutet
Uppsala University Hospital

Investigators

  • Principal Investigator: Brita Arver, MD PhD, Karolinska University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

May 16, 2013

First Submitted That Met QC Criteria

May 19, 2013

First Posted (Estimate)

May 22, 2013

Study Record Updates

Last Update Posted (Estimate)

May 29, 2013

Last Update Submitted That Met QC Criteria

May 27, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • POMB

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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