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

Phase 3
18 Years
Not Enrolling
Breast Cancer

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Trial Information

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

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

Exclusion Criteria:

- Patient is unable to complete a breast MRI due to such factors as hardware and

- 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

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

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

Principal Investigator

Frederick M. Dirbas

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University


United States: Food and Drug Administration

Study ID:




Start Date:

Completion Date:

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms



Stanford University School of Medicine Stanford, California  94305-5317