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Completed

NCT Number: NCT01859936

Will Preoperative MRI Breast in Women Under 56 Years With Breast Cancer 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?

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Key information

Conditions

Breast Neoplasm Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–56 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Karolinska Univeristy Hospital

Stockholm, Stockholm County, 17176, Sweden

About this study

Completed: the study has concluded normally; participants are no longer being examined or treated (i.e., last patient's last visit has occurred)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MRI

Device

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 outcomes

  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 outcomes

  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 outcomes

  1. Is the sensitivity of breast MRI dependant on density and/or on age

    Time frame: 14 days

Sponsors and collaborators

Lead sponsor

Karolinska University Hospital

Other

Collaborators

  • Karolinska Institutet
  • Uppsala University Hospital

Registry information

Official study title

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

Acronym: POMB

Important dates

Study start
2008
Primary completion
2011
Study completion
2013
First posted
May 22, 2013
Registry last updated
May 29, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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