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
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
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Stockholm, Sweden, 17176
- Karolinska Univeristy Hospital
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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 |
|---|---|
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Experimental: preoperative breast MRI
The intervention is that preoperative MRI breast will be performed in women under 56 years with newly diagnosed breast cancer
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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.
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change of treatment plan
Time Frame: 14 days
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Did breast magnetic resonance imaging add information about the tumour that changed primary treatment plan
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14 days
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Did breast magnetic resonance imaging reduce the number of reoperation during primary management
Time Frame: 6 months
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6 months
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Did breast magnetic resonance imaging increase the number of mastectomies
Time Frame: 6 months
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6 months
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Did breast magnetic resonance imaging affect cost
Time Frame: 6 months
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6 months
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Other Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Is the sensitivity of breast MRI dependant on density and/or on age
Time Frame: 14 days
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14 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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.
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.