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

NCT ID: NCT00695916

Last Updated: 2017-02-01

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Interventions

Breast MRI

Intervention Type: PROCEDURE

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.
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frederick M. Dirbas

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Other Identifiers

98272

Identifier Type: OTHER

Identifier Source: secondary_id

BRSNSTU0025

Identifier Type: OTHER

Identifier Source: secondary_id

NCT00695916

Identifier Type: OTHER

Identifier Source: secondary_id

6125

Identifier Type: OTHER

Identifier Source: secondary_id

BRSNSTU0025

Identifier Type: -

Identifier Source: org_study_id