Breast CancerNCT00801476
Pre-operative Magnetic Resonance Imaging (MRI) in Young Breast Cancer Patients
A study testing Pre-operative bilateral breast MRI in people with Breast Cancer and Magnetic Resonance Imaging, run by McMaster University at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 50 years, women only
- Conditions the study is for
- Breast Cancer, Magnetic Resonance Imaging, Preoperative MRI
- What is being tested?
- Pre-operative bilateral breast MRI
- Type of treatment
- Surgery or procedure
- How many people
- 44 participants
- Where
- 2 sitesCanada
- Study dates
- Apr 2008to May 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 50 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Female aged <= 50 years
- Histological proof of invasive breast cancer via fine needle aspiration or core needle biopsy
- Premenopausal
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites, 2 recruiting
- Recruiting
St. Josephs' Healthcare
Hamilton, Ontario, L8N 4A6
Sylvie Cornacchi, 905-521-6060, cornacs@mcmaster.ca
Peter Lovrics, MD
- Recruiting
Juravinski Cancer Centre
Hamilton, Ontario, L8V 5C2
Shelley Chambers, MA, 905-387-9711 ext. 64510, shelley.chambers@jcc.hhsc.ca
Nicole Hodgson, MD
About this study
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
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.
Read the 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
- Conditions
- Breast Cancer, Magnetic Resonance Imaging, Preoperative MRI
- Being tested
- Pre-operative bilateral breast MRI
- Keywords
- Breast Cancer, Magnetic Resonance Imaging, Preoperative MRI
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-operative bilateral breast MRIProcedure or surgery
Also called No "Other names" for this study
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Does pre-operative magnetic resonance imaging (MRI) effect surgical management in young women with breast cancer
Measured: 3 months
Secondary outcomes (3)
Proportion of patients requiring a second surgery due to positive tumour margins.
Measured: 3 months
Incidence of multifocal or multicentric or bilateral breast cancer found on MRI
Measured: After surgery
The correlation between MRI tumour size and the pathologic tumour size after surgery.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2008 (estimated)
- Study startApr 2008
- Primary completionDec 2009 (estimated)
- Study completionMay 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Investigators
- Nicole Hodgson, MD, Principal investigator, Juravinski Cancer CentreSom D Mukherjee, MD, Principal investigator, Juravinski Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00801476
- Sponsor's protocol ID
- MRI REB 07-458
- Status last verified
- Nov 2009
- First submitted
- 2 Dec 2008
- Last updated
- 18 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00801476
- Acronym / sponsor ID
- MRI REB 07-458
- Conditions
- Breast Cancer, Magnetic Resonance Imaging, Preoperative MRI
- Keywords
- Breast Cancer, Magnetic Resonance Imaging, Preoperative MRI
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Dec 2009 (estimated)
- Study completion
- May 2010 (estimated)
- First posted
- 3 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Female aged <= 50 years
- Histological proof of invasive breast cancer via fine needle aspiration or core needle biopsy
- Premenopausal
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pre-operative bilateral breast MRIAlso: No "Other names" for this studyAfter 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. | Procedure or surgery | – |
Primary outcome
Does pre-operative magnetic resonance imaging (MRI) effect surgical management in young women with breast cancer
Time frame: 3 months
3 secondary outcomes
Proportion of patients requiring a second surgery due to positive tumour margins.
Time frame: 3 months
Incidence of multifocal or multicentric or bilateral breast cancer found on MRI
Time frame: After surgery
The correlation between MRI tumour size and the pathologic tumour size after surgery.
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicole Hodgson, MD principal investigator
Juravinski Cancer Centre
Som D Mukherjee, MD principal investigator
Juravinski Cancer Centre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-operative bilateral breast MRI in people with Breast Cancer and Magnetic Resonance Imaging, run by McMaster University at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shelley A Chambers, MA (905-387-9711 ext. 64510, shelley.chambers@jcc.hhsc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Does pre-operative magnetic resonance imaging (MRI) effect surgical management in young women with breast cancer (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2009.