- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01035112
Magnetic Resonance Imaging of Breast Cancer
June 29, 2026 updated by: Stanford University
To compare magnetic resonance imaging (MRI) with more well established diagnostic imaging techniques to determine which method best finds and defines breast cancer.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
500
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jocelyn Steffan
- Phone Number: 650-725-1812
- Email: jsteffen@stanford.edu
Study Locations
-
-
California
-
Stanford, California, United States, 94305
- Recruiting
- Stanford University School of Medicine
-
Contact:
- Jocelyn Steffen
- Phone Number: 650-725-1812
- Email: jsteffen@stanford.edu
-
Principal Investigator:
- Bruce Lewis Daniel
-
Sub-Investigator:
- Brian Andrew Hargreaves
-
Sub-Investigator:
- Robert J Herfkens
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Magnetic Resonance Imaging (MRI) of Breast Cancer
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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.
Time Frame: Length of one MRI scan
|
Length of one MRI scan
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Bruce L Daniel, Stanford University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 1995
Primary Completion (Estimated)
May 1, 2027
Study Completion (Estimated)
May 1, 2027
Study Registration Dates
First Submitted
December 17, 2009
First Submitted That Met QC Criteria
December 17, 2009
First Posted (Estimated)
December 18, 2009
Study Record Updates
Last Update Posted (Actual)
July 1, 2026
Last Update Submitted That Met QC Criteria
June 29, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-10748
- 13IB-0074 (Other Identifier: NIH)
- 75763 (Other Identifier: Stanford IRB (old))
- BRSNSTU0004 (Other Identifier: OnCore)
- R01CA249893 (U.S. NIH Grant/Contract)
- NCI-2024-01929 (Registry Identifier: NCI-Clinical Trials Reporting Program)
- R01EB009055 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.