NCT00801476

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: McMaster University · Academic / Other
• Sex: Female
• Age: 50 Years
• Healthy volunteers: Not accepted

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

Conditions

• Breast Cancer
• Magnetic Resonance Imaging
• Preoperative MRI

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2008-04-01
• Primary completion: 2009-12-01
• Completion: 2010-05-01
• First posted: 2008-12-03
• Last updated: 2009-11-18

Locations

2 sites across 1 country: Canada