search
Back to results

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

Primary Purpose

Breast Cancer

Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Breast MRI
Sponsored by
Stanford University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    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 Measures

    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
    To measure whether preoperative MRI is associated with enhanced postoperative cosmesis
    To measure whether preoperative MRI alters cost of care
    To measure the degree and extent to which preoperative MRI lengthens the time required to deliver care
    To measure whether preoperative MRI increases the rate of patient directed ("unnecessary") mastectomy
    To measure whether MRI decreases the risk of ipsilateral breast tumor recurrence
    To measure disease-free survival without/with preoperative breast MRI
    To measure overall survival without/with preoperative MRI

    Full Information

    First Posted
    June 10, 2008
    Last Updated
    January 30, 2017
    Sponsor
    Stanford University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00695916
    Brief Title
    MRI in Women With Newly Diagnosed Breast Cancer Prior to Breast Conserving Surgery
    Official Title
    Randomized Trial of Breast MRI in Women With Newly Diagnosed Breast Cancer Prior to Breast Conserving Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2017
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    PI
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Stanford University

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Cancer

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Procedure
    Intervention Name(s)
    Breast MRI
    Primary Outcome Measure Information:
    Title
    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 Measure Information:
    Title
    To determine how often MRI will detect occult multifocal or multicentric disease
    Title
    To determine how often MRI will miss occult DCIS or invasive cancer subsequently detected on surgical pathology
    Title
    To determine the frequency with which breast MRI changes the surgical plan
    Title
    To determine the frequency of false positive MRI findings requiring biopsy
    Title
    To measure whether MRI reduces the frequency of repeat lumpectomy to a greater extent in women with mammographically dense vs fatty breasts
    Title
    To measure whether preoperative MRI is associated with enhanced postoperative cosmesis
    Title
    To measure whether preoperative MRI alters cost of care
    Title
    To measure the degree and extent to which preoperative MRI lengthens the time required to deliver care
    Title
    To measure whether preoperative MRI increases the rate of patient directed ("unnecessary") mastectomy
    Title
    To measure whether MRI decreases the risk of ipsilateral breast tumor recurrence
    Title
    To measure disease-free survival without/with preoperative breast MRI
    Title
    To measure overall survival without/with preoperative MRI

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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.&#xA; 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Frederick M. Dirbas
    Organizational Affiliation
    Stanford University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs