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

November 17, 2009 updated by: McMaster University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • Recruiting
        • Juravinski Cancer Centre
        • Principal Investigator:
          • Nicole Hodgson, MD
      • Hamilton, Ontario, Canada, L8N 4A6
        • Recruiting
        • St. Josephs' Healthcare
        • Contact:
        • Principal Investigator:
          • Peter Lovrics, MD
        • Sub-Investigator:
          • Barbara Heller, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 50 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Does pre-operative magnetic resonance imaging (MRI) effect surgical management in young women with breast cancer
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients requiring a second surgery due to positive tumour margins.
Time Frame: 3 months
3 months
Incidence of multifocal or multicentric or bilateral breast cancer found on MRI
Time Frame: After surgery
After surgery
The correlation between MRI tumour size and the pathologic tumour size after surgery.
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McMaster University

Investigators

  • Principal Investigator: Nicole Hodgson, MD, Juravinski Cancer Centre
  • Principal Investigator: Som D Mukherjee, MD, Juravinski Cancer Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Anticipated)

December 1, 2009

Study Completion (Anticipated)

May 1, 2010

Study Registration Dates

First Submitted

December 2, 2008

First Submitted That Met QC Criteria

December 2, 2008

First Posted (Estimate)

December 3, 2008

Study Record Updates

Last Update Posted (Estimate)

November 18, 2009

Last Update Submitted That Met QC Criteria

November 17, 2009

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MRI REB 07-458

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Clinical Trials on Pre-operative bilateral breast MRI

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jamaica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe