Recruiting

MRI

Sponsor:

McMaster University

Code:

NCT00801476

Conditions

Breast Cancer

Magnetic Resonance Imaging

Preoperative MRI

Eligibility Criteria

Sex: Female

Age: 0 - 50

Healthy Volunteers: Not accepted

Interventions

Pre-operative bilateral breast MRI

Study Details

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

Study ID

NCT00801476

Start date

Apr, 2008

Status verified date

Nov, 2009

Completion date

May, 2010

Anticipated

Primary completion date

Dec, 2009

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 0 - 50

Healthy Volunteers: Not accepted

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

Enrollment

44 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Shelley A Chambers, MA

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

Locations

St. Josephs' Healthcare

Recruiting

Hamilton, Ontario, Canada, L8N 4A6

Contacts

Sylvie Cornacchi

905-521-6060cornacs@mcmaster.ca

Principal Investigator:

Peter Lovrics, MD

Juravinski Cancer Centre

Recruiting

Hamilton, Ontario, Canada, L8V 5C2

Contacts

Shelley Chambers, MA

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

Principal Investigator:

Nicole Hodgson, MD

More Information

Sponsor

McMaster University

Last update posted

Nov 18, 2009

Last verified

Nov, 2009

Keywords

  • Breast Cancer
  • Magnetic Resonance Imaging
  • Preoperative MRI

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McMaster University on 2009-11-18.