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

NCT00801476 | Unknown

• 1 other identifier: MRI REB 07-458
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Cancer; Magnetic Resonance Imaging; Preoperative MRI

Keywords

Breast Cancer; Magnetic Resonance Imaging; Preoperative MRI

Outcome Measures

Primary Outcomes (1)

• Does pre-operative magnetic resonance imaging (MRI) effect surgical management in young women with breast cancer

  3 months

Secondary Outcomes (3)

• Proportion of patients requiring a second surgery due to positive tumour margins.

  3 months

• Incidence of multifocal or multicentric or bilateral breast cancer found on MRI

  After surgery

• The correlation between MRI tumour size and the pathologic tumour size after surgery.

  3 months

Interventions

Pre-operative bilateral breast MRI PROCEDURE

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.

Also known as: No "Other names" for this study

Eligibility Criteria

• Age: Up to 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Female aged \<= 50 years
• Histological proof of invasive breast cancer via fine needle aspiration or core needle biopsy
• Premenopausal

You may not qualify if:

• 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.

Sponsors & Collaborators

• McMaster University: lead

Study Sites (2)

St. Josephs' Healthcare

Hamilton, Ontario, L8N 4A6, Canada

RECRUITING

Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Nicole Hodgson, MD

  Juravinski Cancer Centre

  PRINCIPAL INVESTIGATOR

• Som D Mukherjee, MD

  Juravinski Cancer Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shelley A Chambers, MA

CONTACT

905-387-9711; shelley.chambers@jcc.hhsc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 2, 2008
• First Posted: December 3, 2008
• Study Start: April 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: May 1, 2010
• Last Updated: November 18, 2009

Record last verified: 2009-11

Locations

CA (2)