Will Preoperative MRI Breast in Women Under 56 Years With Breast Cancer Change Primary Treatment (POMB)
Primary Purpose
Breast Neoplasm
Status
Completed
Phase
Phase 4
Locations
Sweden
Study Type
Interventional
Intervention
MRI
Sponsored by

About this trial
This is an interventional diagnostic trial for Breast Neoplasm
Eligibility Criteria
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
Sites / Locations
- Karolinska Univeristy Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
preoperative breast MRI
no MRI breast
Arm Description
The intervention is that preoperative MRI breast will be performed in women under 56 years with newly diagnosed breast cancer
The arm type description implies that no MRI breast will be performed to women under 56 years with newly diagnosed breast cancer
Outcomes
Primary Outcome Measures
Change of treatment plan
Did breast magnetic resonance imaging add information about the tumour that changed primary treatment plan
Secondary Outcome Measures
Did breast magnetic resonance imaging reduce the number of reoperation during primary management
Did breast magnetic resonance imaging increase the number of mastectomies
Did breast magnetic resonance imaging affect cost
Full Information
NCT ID
NCT01859936
First Posted
May 16, 2013
Last Updated
May 27, 2013
Sponsor
Karolinska University Hospital
Collaborators
Karolinska Institutet, Uppsala University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01859936
Brief Title
Will Preoperative MRI Breast in Women Under 56 Years With Breast Cancer Change Primary Treatment
Acronym
POMB
Official Title
Randomized Multicenter Trial Assessing if Preoperative MRI Breast in Women Under 56 Years With Breast Cancer Will Change Primary Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
April 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska University Hospital
Collaborators
Karolinska Institutet, Uppsala University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasm
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
440 (Actual)
8. Arms, Groups, and Interventions
Arm Title
preoperative breast MRI
Arm Type
Experimental
Arm Description
The intervention is that preoperative MRI breast will be performed in women under 56 years with newly diagnosed breast cancer
Arm Title
no MRI breast
Arm Type
No Intervention
Arm Description
The arm type description implies that no MRI breast will be performed to women under 56 years with newly diagnosed breast cancer
Intervention Type
Device
Intervention Name(s)
MRI
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of treatment plan
Description
Did breast magnetic resonance imaging add information about the tumour that changed primary treatment plan
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Did breast magnetic resonance imaging reduce the number of reoperation during primary management
Time Frame
6 months
Title
Did breast magnetic resonance imaging increase the number of mastectomies
Time Frame
6 months
Title
Did breast magnetic resonance imaging affect cost
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Is the sensitivity of breast MRI dependant on density and/or on age
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
56 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brita Arver, MD PhD
Organizational Affiliation
Karolinska University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska Univeristy Hospital
City
Stockholm
ZIP/Postal Code
17176
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
34611701
Citation
Gonzalez V, Arver B, Lofgren L, Bergkvist L, Sandelin K, Eriksson S. Impact of preoperative breast MRI on 10-year survival of patients included in the Swedish randomized multicentre POMB trial. BJS Open. 2021 Sep 6;5(5):zrab088. doi: 10.1093/bjsopen/zrab088.
Results Reference
derived
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Will Preoperative MRI Breast in Women Under 56 Years With Breast Cancer Change Primary Treatment
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