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

NCT01859936 | Completed Phase 4

• 1 other identifier: POMB
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 1

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?

Conditions

Breast Neoplasm

Outcome Measures

Primary Outcomes (1)

• Change of treatment plan

  Did breast magnetic resonance imaging add information about the tumour that changed primary treatment plan

  14 days

Secondary Outcomes (3)

• Did breast magnetic resonance imaging reduce the number of reoperation during primary management

  6 months

• Did breast magnetic resonance imaging increase the number of mastectomies

  6 months

• Did breast magnetic resonance imaging affect cost

  6 months

Other Outcomes (1)

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

  14 days

Study Arms (2)

preoperative breast MRI

EXPERIMENTAL

The intervention is that preoperative MRI breast will be performed in women under 56 years with newly diagnosed breast cancer

Device: MRI

no MRI breast

NO INTERVENTION

The arm type description implies that no MRI breast will be performed to women under 56 years with newly diagnosed breast cancer

Interventions

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.

preoperative breast MRI

Eligibility Criteria

• Age: 18 Years - 56 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women under 56 years of age
• Newly diagnosed breast cancer
• Swedish or English speaking

You may not qualify if:

• Claustrophobia
• Pregnancy
• Renal failure
• Metal items in patients

Sponsors & Collaborators

• Karolinska University Hospital: lead
• Karolinska Institutet: collaborator
• Uppsala University Hospital: collaborator

Study Sites (1)

Karolinska Univeristy Hospital

Stockholm, Stockholm County, 17176, Sweden

Location

Related Publications (1)

• 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.

  PMID: 34611701 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Brita Arver, MD PhD

  Karolinska University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: May 16, 2013
• First Posted: May 22, 2013
• Study Start: February 1, 2008
• Primary Completion: February 1, 2011
• Study Completion: April 1, 2013
• Last Updated: May 29, 2013

Record last verified: 2013-05

Locations

SE (1)