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

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ClinicalTrials.gov Identifier: NCT00695916
Recruitment Status : Withdrawn (PI)
First Posted : June 12, 2008
Last Update Posted : February 1, 2017
Information provided by (Responsible Party):
Stanford University

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Procedure: Breast MRI Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Randomized Trial of Breast MRI in Women With Newly Diagnosed Breast Cancer Prior to Breast Conserving Surgery

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Primary Outcome Measures :
  1. 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 :
  1. To determine how often MRI will detect occult multifocal or multicentric disease
  2. To determine how often MRI will miss occult DCIS or invasive cancer subsequently detected on surgical pathology
  3. To determine the frequency with which breast MRI changes the surgical plan
  4. To determine the frequency of false positive MRI findings requiring biopsy
  5. To measure whether MRI reduces the frequency of repeat lumpectomy to a greater extent in women with mammographically dense vs fatty breasts
  6. To measure whether preoperative MRI is associated with enhanced postoperative cosmesis
  7. To measure whether preoperative MRI alters cost of care
  8. To measure the degree and extent to which preoperative MRI lengthens the time required to deliver care
  9. To measure whether preoperative MRI increases the rate of patient directed ("unnecessary") mastectomy
  10. To measure whether MRI decreases the risk of ipsilateral breast tumor recurrence
  11. To measure disease-free survival without/with preoperative breast MRI
  12. To measure overall survival without/with preoperative MRI

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00695916

Sponsors and Collaborators
Stanford University
Principal Investigator: Frederick M. Dirbas Stanford University

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT00695916     History of Changes
Other Study ID Numbers: BRSNSTU0025
98272 ( Other Identifier: Stanford University Alternate IRB Approval Number )
BRSNSTU0025 ( Other Identifier: [Stanford University OnCore Number )
6125 ( Other Identifier: Stanford IRB )
First Posted: June 12, 2008    Key Record Dates
Last Update Posted: February 1, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases