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

Primary Purpose

Breast Cancer, Magnetic Resonance Imaging, Preoperative MRI

Status

Unknown status

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Pre-operative bilateral breast MRI

About this trial

This is an interventional diagnostic trial for Breast Cancer focused on measuring Breast Cancer, Magnetic Resonance Imaging, Preoperative MRI

Eligibility Criteria

undefined - 50 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

St. Josephs' HealthcareRecruiting
Juravinski Cancer CentreRecruiting

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

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

Full Information

NCT ID

NCT00801476

First Posted

December 2, 2008

Last Updated

November 17, 2009

Sponsor

McMaster University

1. Study Identification

Unique Protocol Identification Number

NCT00801476

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2009

Overall Recruitment Status

Unknown status

Study Start Date

April 2008 (undefined)

Primary Completion Date

December 2009 (Anticipated)

Study Completion Date

May 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

McMaster University

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer, Magnetic Resonance Imaging, Preoperative MRI

Keywords

Breast Cancer, Magnetic Resonance Imaging, Preoperative MRI

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

44 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

Pre-operative bilateral breast MRI

Other Intervention Name(s)

No "Other names" for this study

Intervention Description

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 Information:

Title

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

Time Frame

3 months

Secondary Outcome Measure Information:

Title

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

Time Frame

3 months

Title

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

Time Frame

After surgery

Title

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

Time Frame

3 months

10. Eligibility

Sex

Female

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Shelley A Chambers, MA

Phone

905-387-9711

Ext

64510

shelley.chambers@jcc.hhsc.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nicole Hodgson, MD

Organizational Affiliation

Juravinski Cancer Centre

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Som D Mukherjee, MD

Organizational Affiliation

Juravinski Cancer Centre

Official's Role

Principal Investigator

Facility Information:

Facility Name

St. Josephs' Healthcare

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8N 4A6

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sylvie Cornacchi

Phone

905-521-6060

cornacs@mcmaster.ca

First Name & Middle Initial & Last Name & Degree

Peter Lovrics, MD

First Name & Middle Initial & Last Name & Degree

Barbara Heller, MD

Facility Name

Juravinski Cancer Centre

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8V 5C2

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Shelley Chambers, MA

Phone

905-387-9711

Ext

64510

shelley.chambers@jcc.hhsc.ca

First Name & Middle Initial & Last Name & Degree

Nicole Hodgson, MD

12. IPD Sharing Statement

Learn more about this trial

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

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