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

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ClinicalTrials.gov Identifier: NCT01859936
Recruitment Status : Completed
First Posted : May 22, 2013
Last Update Posted : May 29, 2013
Sponsor:
Collaborators:
Karolinska Institutet
Uppsala University Hospital
Information provided by (Responsible Party):
Brita Arver, Karolinska University Hospital

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?

Condition or disease Intervention/treatment Phase
Breast Neoplasm Device: MRI Phase 4

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)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 440 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Randomized Multicenter Trial Assessing if Preoperative MRI Breast in Women Under 56 Years With Breast Cancer Will Change Primary Treatment
Study Start Date : February 2008
Actual Primary Completion Date : February 2011
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: preoperative breast MRI
The intervention is that preoperative MRI breast will be performed in women under 56 years with newly diagnosed breast cancer
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.

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



Primary Outcome Measures :
  1. Change of treatment plan [ Time Frame: 14 days ]
    Did breast magnetic resonance imaging add information about the tumour that changed primary treatment plan


Secondary Outcome Measures :
  1. Did breast magnetic resonance imaging reduce the number of reoperation during primary management [ Time Frame: 6 months ]
  2. Did breast magnetic resonance imaging increase the number of mastectomies [ Time Frame: 6 months ]
  3. Did breast magnetic resonance imaging affect cost [ Time Frame: 6 months ]

Other Outcome Measures:
  1. Is the sensitivity of breast MRI dependant on density and/or on age [ Time Frame: 14 days ]


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Ages Eligible for Study:   18 Years to 56 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01859936


Locations
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Sweden
Karolinska Univeristy Hospital
Stockholm, Sweden, 17176
Sponsors and Collaborators
Karolinska University Hospital
Karolinska Institutet
Uppsala University Hospital
Investigators
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Principal Investigator: Brita Arver, MD PhD Karolinska University Hospital

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Responsible Party: Brita Arver, MD, PhD, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT01859936     History of Changes
Other Study ID Numbers: POMB
First Posted: May 22, 2013    Key Record Dates
Last Update Posted: May 29, 2013
Last Verified: May 2013
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases