Pre-operative Magnetic Resonance Imaging (MRI) in Young Breast Cancer Patients
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Inclusion Criteria:
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female aged ≤ 50
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histologically proven invasive breast cancer
Exclusion Criteria:
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Is not considered a surgical candidate
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Has had prior breast cancer surgery or an excisional biopsy of the newly diagnosed lesion
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Has a contraindication to undergoing breast MRI
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Has inflammatory breast cancer according to the standard clinical definition
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Has locally advanced breast cancer according to the standard clinical definition
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Patient is pregnant
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Has a psychiatric or addictive disorder that would preclude obtaining informed consent or adherence to the protocol
Study Design
Outcome Measures
Primary Outcome Measures
- Does pre-operative magnetic resonance imaging (MRI) effect surgical management in young women with breast cancer [3 months]
Secondary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Female aged <= 50 years
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Histological proof of invasive breast cancer via fine needle aspiration or core needle biopsy
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Premenopausal
Exclusion Criteria:
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Patient not considered an appropriate surgical candidate; i.e., patient is not well enough to have breast cancer surgery
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Patient has had prior breast cancer surgery or an excisional biopsy of the newly diagnosed cancer
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Patient has a contraindication to undergoing breast MRI (i.e., pacemaker, neurodefibrillator, metallic foreign bodies, etc.)
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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.
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Patient has locally advanced breast cancer according to the standard clinical definition.
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Patient is pregnant
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Patient has a psychiatric or addictive disorder that would preclude them from obtaining informed consent.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | St. Josephs' Healthcare | Hamilton | Ontario | Canada | L8N 4A6 |
| 2 | Juravinski Cancer Centre | Hamilton | Ontario | Canada | L8V 5C2 |
Sponsors and Collaborators
- McMaster University
Investigators
- Principal Investigator: Nicole Hodgson, MD, Juravinski Cancer Centre
- Principal Investigator: Som D Mukherjee, MD, Juravinski Cancer Centre
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MRI REB 07-458