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

NCT ID: NCT01859936

Last Updated: 2013-05-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 440 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2013-04-30

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)

Conditions

Breast Neoplasm

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

preoperative breast MRI

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

Group Type: EXPERIMENTAL

MRI

Intervention Type: 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.

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 56 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: collaborator

Uppsala University Hospital

OTHER

Sponsor Role: collaborator

Karolinska University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Brita Arver

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brita Arver, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska University Hospital

Locations

Karolinska Univeristy Hospital

Stockholm, Stockholm County, Sweden

Countries

Sweden

References

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.

Reference Type: DERIVED

PMID: 34611701 (View on PubMed)

Other Identifiers

POMB

Identifier Type: -

Identifier Source: org_study_id