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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by McMaster University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT00801476
First received: December 2, 2008
Last updated: November 17, 2009
Last verified: November 2009
  Purpose

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.


Condition Intervention
Breast Cancer
Magnetic Resonance Imaging
Preoperative MRI
Procedure: Pre-operative bilateral breast MRI

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

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Does pre-operative magnetic resonance imaging (MRI) effect surgical management in young women with breast cancer [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of patients requiring a second surgery due to positive tumour margins. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Incidence of multifocal or multicentric or bilateral breast cancer found on MRI [ Time Frame: After surgery ] [ Designated as safety issue: No ]
  • The correlation between MRI tumour size and the pathologic tumour size after surgery. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 44
Study Start Date: April 2008
Estimated Study Completion Date: May 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
    Other Name: No "Other names" for this study
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
  Eligibility

Ages Eligible for Study:   up to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00801476

Contacts
Contact: Shelley A Chambers, MA 905-387-9711 ext 64510 shelley.chambers@jcc.hhsc.ca

Locations
Canada, Ontario
Juravinski Cancer Centre Recruiting
Hamilton, Ontario, Canada, L8V 5C2
Contact: Shelley Chambers, MA    905-387-9711 ext 64510    shelley.chambers@jcc.hhsc.ca   
Principal Investigator: Nicole Hodgson, MD         
St. Josephs' Healthcare Recruiting
Hamilton, Ontario, Canada, L8N 4A6
Contact: Sylvie Cornacchi    905-521-6060    cornacs@mcmaster.ca   
Principal Investigator: Peter Lovrics, MD         
Sub-Investigator: Barbara Heller, MD         
Sponsors and Collaborators
McMaster University
Investigators
Principal Investigator: Nicole Hodgson, MD Juravinski Cancer Centre
Principal Investigator: Som D Mukherjee, MD Juravinski Cancer Centre
  More Information

No publications provided

Responsible Party: Dr. Nicole Hodgson, Juravinski Cancer Centre
ClinicalTrials.gov Identifier: NCT00801476     History of Changes
Other Study ID Numbers: MRI REB 07-458
Study First Received: December 2, 2008
Last Updated: November 17, 2009
Health Authority: Canada: Health Canada

Keywords provided by McMaster University:
Breast Cancer
Magnetic Resonance Imaging
Preoperative MRI

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 16, 2014