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

Karolinska University Hospital

Status and phase: Completed; Phase 4

Conditions: Breast Neoplasm

Treatments: Device: MRI

Study type: Interventional

Funder types: Other

Identifiers

NCT01859936

POMB

Details and patient eligibility

About

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?

Full description

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

Enrollment: 440 patients

Sex: All

Ages: 18 to 56 years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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440 participants in 2 patient groups

preoperative breast MRI

Experimental group

Description:

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

Treatment:

Device: MRI

no MRI breast

No Intervention group

Description:

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