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

Not Applicable

• Conditions: Breast Cancer; Magnetic Resonance Imaging; Preoperative MRI

• Registration Number: NCT00801476
• Lead Sponsor: McMaster University

Brief Summary

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

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

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-12-02
• Study First Submitted QC: 2008-12-02
• Study First Posted: 2008-12-03
• Status Verified: 2009-11
• Last Update Submitted: 2009-11-17
• Last Update Posted: 2009-11-18
• Primary Completion: 2009-12
• Study Completion: 2010-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 44

Inclusion Criteria

• Female aged <= 50 years
• Histological proof of invasive breast cancer via fine needle aspiration or core needle biopsy
• Premenopausal

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Does pre-operative magnetic resonance imaging (MRI) effect surgical management in young women with breast cancer	3 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Juravinski Cancer Centre; 🇨🇦 Hamilton, Ontario, Canada

St. Josephs' Healthcare; 🇨🇦 Hamilton, Ontario, Canada