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

Breast Cancer Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Magnetic Resonance Imaging
• Preoperative MRI

• NCT number: NCT00801476
• Study type: Interventional
• Source: McMaster University
• Contact: Shelley A Chambers, MA
• Phone: 905-387-9711
• Email: shelley.chambers@jcc.hhsc.ca
• Status: Recruiting
• Phase: N/A
• Start date: April 2008
• Completion date: May 2010