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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
Karolinska University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Neoplasm

Eligibility Criteria

18 Years - 56 Years (Adult)All SexesDoes not accept 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

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

First Posted
May 16, 2013
Last Updated
May 27, 2013
Sponsor
Karolinska University Hospital
Collaborators
Karolinska Institutet, Uppsala University Hospital
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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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