Pre-operative Magnetic Resonance Imaging (MRI) in Young Breast Cancer Patients

Study Overview
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Brief Summary
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Young women with breast cancer have an increased breast tissue density and conventional imaging tests such as mammography and breast ultrasound are less sensitive and specific for detecting breast cancer than in older breast cancer patients. Breast MRI is an emerging tool that has been proven to improve the ability to identify breast cancers by determining the extent of disease and also detect multifocal, multicentric and bilateral breast cancers. To date, the role of pre-operative breast MRI is not clearly defined. The investigators are proposing a study to evaluate the impact of preoperative breast MRI on surgical decision-making in breast cancer patients <= 50 years. This may lead to improved characterization of breast cancers in these younger patients that may ultimately result in lower local recurrence rates in the future. The additional information attained through the breast MRI may also guide the use of radiation, chemotherapy and/or hormonal therapy in these patients.

Detailed Description
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Inclusion Criteria: female aged ≤ 50 histologically proven invasive breast cancer Exclusion Criteria: Is not considered a surgical candidate Has had prior breast cancer surgery or an excisional biopsy of the newly diagnosed lesion Has a contraindication to undergoing breast MRI Has inflammatory breast cancer according to the standard clinical definition Has locally advanced breast cancer according to the standard clinical definition Patient is pregnant Has a psychiatric or addictive disorder that would preclude obtaining informed consent or adherence to the protocol

Official Title
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A Prospective Cohort Study to Evaluate the Impact of Preoperative Breast Magnetic Resonance Imaging (MRI) on Surgical Decision-Making in Young Patients With Breast Cancer

Conditions
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Breast Cancer, Magnetic Resonance Imaging, Preoperative MRI

Intervention / Treatment
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* Procedure: Pre-operative bilateral breast MRI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female aged <= 50 years Histological proof of invasive breast cancer via fine needle aspiration or core needle biopsy Premenopausal Exclusion Criteria: Patient not considered an appropriate surgical candidate; i.e., patient is not well enough to have breast cancer surgery Patient has had prior breast cancer surgery or an excisional biopsy of the newly diagnosed cancer Patient has a contraindication to undergoing breast MRI (i.e., pacemaker, neurodefibrillator, metallic foreign bodies, etc.) Patient has inflammatory breast cancer according to the standard clinical definition. This is a type of breast cancer in which there is evidence of erythema and/or edema. The skin of the breast may also have changes of peau d'orange. Patient has locally advanced breast cancer according to the standard clinical definition. Patient is pregnant Patient has a psychiatric or addictive disorder that would preclude them from obtaining informed consent.

Ages Eligible for Study
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Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Pre-operative bilateral breast MRI|After the standard mammogram and ultrasound testing, the surgeon is asked which surgical procedure they feel is appropriate for the patient. A bilateral breast MRI is then performed prior to surgery. The surgeon is again asked which surgery they feel is appropriate based on the new information provided by the MRI. The study is trying to see if this pre-operative breast MRI helps define the tumour leading to a better first surgical decision.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Does pre-operative magnetic resonance imaging (MRI) effect surgical management in young women with breast cancer |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients requiring a second surgery due to positive tumour margins. |  | 3 months | 
| Incidence of multifocal or multicentric or bilateral breast cancer found on MRI |  | After surgery | 
| The correlation between MRI tumour size and the pathologic tumour size after surgery. |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Magnetic Resonance Imaging, Preoperative MRI