MRI in Women With Newly Diagnosed Breast Cancer Prior to... | NCT00695916

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

NCT00695916

Sponsor

Stanford University

Status

Withdrawn

Last Update Posted

Feb 1, 2017Estimated

Enrollment

0Actual

Phase

Phase 3

Conditions

Breast Cancer

Interventions

Breast MRI

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description
98272	Other Identifier	Stanford University Alternate IRB Approval Number
BRSNSTU0025	Other Identifier	[Stanford University OnCore Number
NCT00695916	Other Identifier	ClinicalTrails.gov
6125	Other Identifier	Stanford IRB

Status Module

Record Verification Date

Jan 2017

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jun 10, 2008

First Submission Date that Met QC Criteria

Jun 10, 2008

First Posted Date

Jun 12, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 30, 2017

Last Update Posted Date

Feb 1, 2017Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Name	Type	Description	Arm Group Labels	Other Names
Breast MRI	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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.
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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases