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Clinical Trials/NCT00801476
NCT00801476
Unknown
Not Applicable

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

McMaster University2 sites in 1 country44 target enrollmentApril 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
McMaster University
Enrollment
44
Locations
2
Primary Endpoint
Does pre-operative magnetic resonance imaging (MRI) effect surgical management in young women with breast cancer
Last Updated
16 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
April 2008
End Date
May 2010
Last Updated
16 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Does pre-operative magnetic resonance imaging (MRI) effect surgical management in young women with breast cancer

Time Frame: 3 months

Secondary Outcomes

  • 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)

Study Sites (2)

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