Magnetic Resonance Imaging of Breast Cancer | NCT01035112

Studies
Magnetic Resonance Imaging of Breast Cancer

NCT01035112

Sponsor

Stanford University

Status

Recruiting

Last Update Posted

Jul 1, 2026Actual

Enrollment

500Estimated

Phase

Not Applicable

Conditions

Breast Cancer
Breast Cancer Non-invasive Breast Cancer

Interventions

Countries

United States

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	Link
13IB-0074	Other Identifier	NIH
75763	Other Identifier	Stanford IRB (old)
R01CA249893	U.S. NIH Grant/Contract		View source
BRSNSTU0004	Other Identifier	OnCore
NCI-2024-01929	Registry Identifier	NCI-Clinical Trials Reporting Program
R01EB009055	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 1995Actual

Primary Completion Date

May 2027Estimated

Completion Date

May 2027Estimated

First Submitted Date

Dec 17, 2009

First Submission Date that Met QC Criteria

Dec 17, 2009

First Posted Date

Dec 18, 2009Estimated

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

Jun 29, 2026

Last Update Posted Date

Jul 1, 2026Actual

Name	Class
National Cancer Institute (NCI)	NIH
National Institutes of Health (NIH)	NIH
National Institute for Biomedical Imaging and Bioengineering (NIBIB)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To compare magnetic resonance imaging (MRI) with more well established diagnostic imaging techniques to determine which method best finds and defines breast cancer.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Magnetic Resonance Imaging (MRI) of Breast Cancer	Experimental	Contrast-enhanced magnetic resonance imaging (MRI) using the standard department of Radiology MRI screening procedures. The duration of scanning may be variable, but will not exceed 90 minutes.	Procedure: MRI

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MRI	Procedure		Magnetic Resonance Imaging (MRI) of Breast Cancer

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To compare magnetic resonance imaging (MRI) with more well established diagnostic imaging techniques to determine which method best finds and defines breast cancer.		Length of one MRI scan

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

INCLUSION CRITERIA

Female
Documented breast physical examination,
Documented mammography within 3 months of the MR studies
Palpable or mammographically-detected suspect breast lesions
Women who have already undergone lumpectomy for breast cancer and have post-biopsy/post-radiation changes will be eligible if they have mammographically-detected or palpable breast abnormalities which are sufficiently suspicious to merit core needle or surgical biopsy.

EXCLUSION CRITERIA:

Male by birth
Able to complete the MR examination. Subjects will be interviewed by one of the investigators for the usual contraindications to
MR contraindications including
Pacemakers
Metallic implants
Severe claustrophobia
Aneurysm clips
Pregnancy
Current lactation
Other conditions precluding proximity to a strong magnetic field.
Received an enhanced MR procedure within 48 hours,
Iodinated contrast within six hours,
Known sensitivity to MR contrast agents,
Not likely to complete the study in full or
Other clinical reason which would preclude participation in the protocol.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

female by birth

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jocelyn Steffan	Contact	650-725-1812		jsteffen@stanford.edu

Overall Officials

Name	Affiliation	Role
Bruce L Daniel	Stanford University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stanford University School of Medicine	Recruiting	Stanford	California	94305	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided