Clinical trial NCT00801476: Pre-operative Magnetic Resonance Imaging (MRI) in Young Breast Cancer Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Magnetic Resonance Imaging
Preoperative MRI
Keywords: Breast Cancer
Magnetic Resonance Imaging
Preoperative MRI
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2008-12-03
Enrollment: 44
Sex: FEMALE
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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

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.

Primary outcomes:
measure: Does pre-operative magnetic resonance imaging (MRI) effect surgical management in young women with breast cancer
timeFrame: 3 months
Secondary outcomes:
measure: Proportion of patients requiring a second surgery due to positive tumour margins.
timeFrame: 3 months
measure: Incidence of multifocal or multicentric or bilateral breast cancer found on MRI
timeFrame: After surgery
measure: The correlation between MRI tumour size and the pathologic tumour size after surgery.
timeFrame: 3 months
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St. Josephs' Healthcare
state: Ontario
city: Hamilton
country: Canada
facility: Juravinski Cancer Centre
state: Ontario
Study officials:
affiliation: Juravinski Cancer Centre
name: Nicole Hodgson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Juravinski Cancer Centre
name: Som D Mukherjee, MD
role: PRINCIPAL_INVESTIGATOR
References: