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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00801476
• Other study ID #: MRI REB 07-458
• Status: Recruiting
• Phase: N/A
• First received: December 2, 2008
• Last updated: November 17, 2009
• Start date: April 2008
• Est. completion date: May 2010

Study information

• Verified date: November 2009
• Source: McMaster University
• Contact: Shelley A Chambers, MA
• Phone: 905-387-9711
• Email: shelley.chambers[@]jcc.hhsc.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: May 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 50 Years

Eligibility

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.

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

Intervention

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.

Locations

Country	Name	City	State
Canada	Juravinski Cancer Centre	Hamilton	Ontario
Canada	St. Josephs' Healthcare	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
McMaster University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Does pre-operative magnetic resonance imaging (MRI) effect surgical management in young women with breast cancer		3 months	No
Secondary	Proportion of patients requiring a second surgery due to positive tumour margins.		3 months	No
Secondary	Incidence of multifocal or multicentric or bilateral breast cancer found on MRI		After surgery	No
Secondary	The correlation between MRI tumour size and the pathologic tumour size after surgery.		3 months	No