Back to resultsMRI in Women With Newly Diagnosed Breast Cancer Prior to Breast Conserving Surgery
Primary Purpose
Breast Cancer
Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Breast MRI
Sponsored by
About this trial
This is an interventional diagnostic trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- DCIS less than 5 cm. T1/T2 invasive breast cancer. Patient is a suitable candidate for breast conservation and wishes this as the primary clinical approach
- No breast MRI within the past year. Prior core biopsy, but no prior excision allowed. Patient has completed conventional imaging workup with mammography ultrasound as indicated and there is no clinical indication for breast MRI.
- Women with age >= 18. No ethnic restrictions.
- No life expectancy restrictions.
- Performance status not a factor.
- No requirements for organ or marrow function.
- Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:
- Patient is unable to complete a breast MRI due to such factors as hardware and claustrophobia.
- No limitations as to other investigational agents. Patients who have received neoadjuvant chemotherapy will not be included in the study due to the limitations of MRI interpretation after neoadjuvant chemotherapy and because this represents a distinct scenario for interpretation of breast MRI in comparison with untreated patients.
- There are no comorbidities that would preclude entry into the study unless the patient is unable to lay still for breast MRI scanning.
- There are fewer reactions to MRI contrast media, but if there is such a history, the patient will be excluded from consideration.
- There are no exclusion criteria based on concomitant medications.
- There are no other agent specific exclusion criteria.
- Pregnancy is considered a contraindication given the uncertain effects of breast MRI on the fetus.
- Cancer survivors are candidates for the study unless the patient has a prior ipsilateral breast tumor.
Sites / Locations
Outcomes
Primary Outcome Measures
To determine whether pre-lumpectomy breast MRI reduces the frequency of repeat lumpectomy in women with DCIS < 5 cm or T1 or T2 invasive breast cancer
Secondary Outcome Measures
To determine how often MRI will detect occult multifocal or multicentric disease
To determine how often MRI will miss occult DCIS or invasive cancer subsequently detected on surgical pathology
To determine the frequency with which breast MRI changes the surgical plan
To determine the frequency of false positive MRI findings requiring biopsy
To measure whether MRI reduces the frequency of repeat lumpectomy to a greater extent in women with mammographically dense vs fatty breasts
To measure whether preoperative MRI is associated with enhanced postoperative cosmesis
To measure whether preoperative MRI alters cost of care
To measure the degree and extent to which preoperative MRI lengthens the time required to deliver care
To measure whether preoperative MRI increases the rate of patient directed ("unnecessary") mastectomy
To measure whether MRI decreases the risk of ipsilateral breast tumor recurrence
To measure disease-free survival without/with preoperative breast MRI
To measure overall survival without/with preoperative MRI
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00695916
Brief Title
MRI in Women With Newly Diagnosed Breast Cancer Prior to Breast Conserving Surgery
Official Title
Randomized Trial of Breast MRI in Women With Newly Diagnosed Breast Cancer Prior to Breast Conserving Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Withdrawn
Why Stopped
PI
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stanford University
4. Oversight
5. Study Description
Brief Summary
To see if performing breast MRI before a lumpectomy will help the surgeon successfully remove the entire cancer with normal tissue margins in a single operation thereby reducing the need for additional surgical procedures. The study will also measure how well MRI can find unsuspected cancers in the same breast as the known cancer; how well MRI will find unsuspected cancers in the opposite breast; how often MRI will generate false positive MRI findings; whether routinely incorporating breast MRI delays care or adds unnecessary cost; and, whether breast MRI is able to reduce the frequency of cancer recurrence in the treated breast or elsewhere in the body.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Breast MRI
Primary Outcome Measure Information:
Title
To determine whether pre-lumpectomy breast MRI reduces the frequency of repeat lumpectomy in women with DCIS < 5 cm or T1 or T2 invasive breast cancer
Secondary Outcome Measure Information:
Title
To determine how often MRI will detect occult multifocal or multicentric disease
Title
To determine how often MRI will miss occult DCIS or invasive cancer subsequently detected on surgical pathology
Title
To determine the frequency with which breast MRI changes the surgical plan
Title
To determine the frequency of false positive MRI findings requiring biopsy
Title
To measure whether MRI reduces the frequency of repeat lumpectomy to a greater extent in women with mammographically dense vs fatty breasts
Title
To measure whether preoperative MRI is associated with enhanced postoperative cosmesis
Title
To measure whether preoperative MRI alters cost of care
Title
To measure the degree and extent to which preoperative MRI lengthens the time required to deliver care
Title
To measure whether preoperative MRI increases the rate of patient directed ("unnecessary") mastectomy
Title
To measure whether MRI decreases the risk of ipsilateral breast tumor recurrence
Title
To measure disease-free survival without/with preoperative breast MRI
Title
To measure overall survival without/with preoperative MRI
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
DCIS less than 5 cm. T1/T2 invasive breast cancer. Patient is a suitable candidate for breast conservation and wishes this as the primary clinical approach
No breast MRI within the past year. Prior core biopsy, but no prior excision allowed. Patient has completed conventional imaging workup with mammography ultrasound as indicated and there is no clinical indication for breast MRI.
Women with age >= 18. No ethnic restrictions.
No life expectancy restrictions.
Performance status not a factor.
No requirements for organ or marrow function.
Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:
Patient is unable to complete a breast MRI due to such factors as hardware and claustrophobia.
No limitations as to other investigational agents. Patients who have received neoadjuvant chemotherapy will not be included in the study due to the limitations of MRI interpretation after neoadjuvant chemotherapy and because this represents a distinct scenario for interpretation of breast MRI in comparison with untreated patients.
There are no comorbidities that would preclude entry into the study unless the patient is unable to lay still for breast MRI scanning.
There are fewer reactions to MRI contrast media, but if there is such a history, the patient will be excluded from consideration.
There are no exclusion criteria based on concomitant medications.
There are no other agent specific exclusion criteria.
Pregnancy is considered a contraindication given the uncertain effects of breast MRI on the fetus.
Cancer survivors are candidates for the study unless the patient has a prior ipsilateral breast tumor.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederick M. Dirbas
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
MRI in Women With Newly Diagnosed Breast Cancer Prior to Breast Conserving Surgery
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