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

NCT ID: NCT00801476

Last Updated: 2009-11-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2010-05-31

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

Conditions

Breast Cancer; Magnetic Resonance Imaging; Preoperative MRI

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Interventions

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.

Intervention Type: PROCEDURE

Other Intervention Names

No "Other names" for this study

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.

• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

McMaster University

OTHER

Sponsor Role: lead

Responsible Party

Juravinski Cancer Centre

Principal Investigators

Nicole Hodgson, MD

Role: PRINCIPAL_INVESTIGATOR

Juravinski Cancer Centre

Som D Mukherjee, MD

Role: PRINCIPAL_INVESTIGATOR

Juravinski Cancer Centre

Locations

St. Josephs' Healthcare

Hamilton, Ontario, Canada

Site Status: RECRUITING

Juravinski Cancer Centre

Hamilton, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Shelley A Chambers, MA

Role: CONTACT

shelley.chambers@jcc.hhsc.ca

905-387-9711 ext. 64510

Facility Contacts

Sylvie Cornacchi

Role: primary

cornacs@mcmaster.ca

905-521-6060

Shelley Chambers, MA

Role: primary

shelley.chambers@jcc.hhsc.ca

905-387-9711 ext. 64510

Other Identifiers

MRI REB 07-458

Identifier Type: -

Identifier Source: org_study_id