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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT00695916
• Date of registration: 10/06/2008
• Prospective Registration: Yes
• Primary sponsor: Stanford University
• Public title: MRI in Women With Newly Diagnosed Breast Cancer Prior to Breast Conserving Surgery
• Scientific title: Randomized Trial of Breast MRI in Women With Newly Diagnosed Breast Cancer Prior to Breast Conserving Surgery
• Date of first enrolment: September 2008
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT00695916
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

United States

Contacts

• Name: Frederick M. Dirbas
• Affiliation: Stanford University

Key inclusion & exclusion 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.

- 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Breast Cancer

Intervention(s)

Procedure: Breast MRI

Primary Outcome(s)

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(s)

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 measure the degree and extent to which preoperative MRI lengthens the time required to deliver care

To measure whether preoperative MRI is associated with enhanced postoperative cosmesis

To determine the frequency of false positive MRI findings requiring biopsy

To measure whether preoperative MRI alters cost of care

To measure whether MRI decreases the risk of ipsilateral breast tumor recurrence

To measure whether preoperative MRI increases the rate of patient directed ("unnecessary") mastectomy

To measure disease-free survival without/with preoperative breast MRI

To measure whether MRI reduces the frequency of repeat lumpectomy to a greater extent in women with mammographically dense vs fatty breasts

To determine how often MRI will detect occult multifocal or multicentric disease

To measure overall survival without/with preoperative MRI

Secondary ID(s)

98272

6125

BRSNSTU0025

Source(s) of Monetary Support

Please refer to primary and secondary sponsors