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

NCT00695916 | Withdrawn Phase 3

• 4 other identifiers: BRSNSTU002598272NCT006959166125
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (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 Outcomes (12)

• 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

Interventions

Breast MRI PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Frederick M. Dirbas

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2008
• First Posted: June 12, 2008
• Last Updated: February 1, 2017

Record last verified: 2017-01