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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01859936

Acronym

POMB

Enrollment

440

Registered

2013-05-22

Start date

2008-02-29

Completion date

2013-04-30

Last updated

2013-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasm

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)

Interventions

DEVICEMRI

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 56 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Other

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

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026