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
Recruitment status was Recruiting
Sponsor:
McMaster University
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT00801476
First received: December 2, 2008
Last updated: November 17, 2009
Last verified: November 2009
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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:
Detailed Description:
-
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
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
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 May 22, 2013