MRI in Women With Newly Diagnosed Breast Cancer Prior to Breast Conserving Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00695916
Recruitment Status : Withdrawn (PI)
First Posted : June 12, 2008
Last Update Posted : February 1, 2017
Information provided by (Responsible Party):
Stanford University

June 10, 2008
June 12, 2008
February 1, 2017
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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
Same as current
Complete list of historical versions of study NCT00695916 on Archive Site
  • 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
Same as current
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MRI in Women With Newly Diagnosed Breast Cancer Prior to Breast Conserving Surgery
Randomized Trial of Breast MRI in Women With Newly Diagnosed Breast Cancer Prior to Breast Conserving Surgery
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.
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Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Breast Cancer
Procedure: Breast MRI
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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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.&#xA;

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.
Sexes Eligible for Study: Female
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
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United States
98272 ( Other Identifier: Stanford University Alternate IRB Approval Number )
BRSNSTU0025 ( Other Identifier: [Stanford University OnCore Number )
6125 ( Other Identifier: Stanford IRB )
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Stanford University
Stanford University
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Principal Investigator: Frederick M. Dirbas Stanford University
Stanford University
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP