Magnetic Resonance Imaging of Breast Cancer

June 27, 2025 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

Conditions

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

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Recruiting
        • Stanford University School of Medicine
        • Contact:
        • 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.
Procedure: MRI

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

Stanford University

Collaborators

National Cancer Institute (NCI)
National Institutes of Health (NIH)

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 2, 2025

Last Update Submitted That Met QC Criteria

June 27, 2025

Last Verified

June 1, 2025

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)

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.

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