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

Stanford University

Status and phase

Withdrawn

Phase 3

Conditions

Breast Cancer

Treatments

Procedure: Breast MRI

Study type

Interventional

Funder types

Other

Identifiers

NCT00695916

98272 (Other Identifier)

NCT00695916 (Other Identifier)

6125 (Other Identifier)

BRSNSTU0025 (Other Identifier)

Details and patient eligibility

About

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.

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.