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

Breast Neoplasm Clinical Trial

— POMB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01859936
• Other study ID #: POMB
• Status: Completed
• Phase: Phase 4
• First received: May 16, 2013
• Last updated: May 27, 2013
• Start date: February 2008
• Est. completion date: April 2013

Study information

• Verified date: May 2013
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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?

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 information / eligibility

• Status: Completed
• Enrollment: 440
• Est. completion date: April 2013
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 56 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Neoplasm
• Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Sweden	Karolinska Univeristy Hospital	Stockholm

Sponsors (3)

Lead Sponsor	Collaborator
Karolinska University Hospital	Karolinska Institutet, Uppsala University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Is the sensitivity of breast MRI dependant on density and/or on age		14 days	No
Primary	Change of treatment plan	Did breast magnetic resonance imaging add information about the tumour that changed primary treatment plan	14 days	No
Secondary	Did breast magnetic resonance imaging reduce the number of reoperation during primary management		6 months	No
Secondary	Did breast magnetic resonance imaging increase the number of mastectomies		6 months	No
Secondary	Did breast magnetic resonance imaging affect cost		6 months	No