Magnetic Resonance Imaging of Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01035112
Recruitment Status : Recruiting
First Posted : December 18, 2009
Last Update Posted : May 30, 2017
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Stanford University

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.

Condition or disease Intervention/treatment
Breast Cancer Breast Cancer Non-invasive Breast Cancer Procedure: MRI

Study Type : Observational
Estimated Enrollment : 445 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Magnetic Resonance Imaging of Breast Cancer
Study Start Date : April 1995
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Contrast-enhanced 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

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women referred for MRI or mammography by their physicians to the Stanford department of Radiology or from referrals from the Stanford Oncology Divison, the Stanford Radiation Oncology Department, and the Stanford Surgery Department.

Inclusion Criteria:

Women will have already undergone a breast physical examination, will have had mammography within three months of their MR studies, and if they have not had this study, will mammography after their MR examinations.

Women with palpable or mammographically-detected suspect breast lesions with or without breast implants will be imaged. Women who are at high risk for breast cancer may also be included since these women commonly require breast MRI screening. Since some patients may have had recent core-needle biopsies and may have recent post-needle biopsy changes but plan follow-up mastectomies or excision of the biopsy site (complete re-excision), we will include this group. This will allow us to obtain the broad spectrum of post-needle biopsy findings since it is a common procedure that is used prior to biopsy to evaluate patients for potential cancer multicentricity or multifocality. 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:

The low incidence of male breast cancer precludes a significant participation of men in the program and men will be excluded. Patients must be able to complete an MR examination. Subjects will be interviewed by one of the investigators for the usual contraindications to MR including pacemakers, metallic implants, severe claustrophobia, aneurysm clips, pregnancy, current lactation, or other conditions precluding proximity to a strong magnetic field. These patients will be excluded if these contraindications are present.

Other patients will be excluded from the MR study if they have had an enhanced MR procedure within 48 hours, had iodinated contrast within six hours, had known sensitivity to MR contrast agents, are not likely to complete the study in full or have another clinical reason which would preclude participation in the protocol.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01035112

United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Sumita Sood    650-723-0618   
Contact: Cancer Clinical Trials Office    (650) 498-7061      
Principal Investigator: Bruce Lewis Daniel         
Sub-Investigator: Brian Andrew Hargreaves         
Sub-Investigator: Robert J Herfkens         
Sponsors and Collaborators
Stanford University
National Institutes of Health (NIH)
Principal Investigator: Bruce Lewis Daniel Stanford University

Responsible Party: Stanford University Identifier: NCT01035112     History of Changes
Other Study ID Numbers: BRSNSTU0004
13IB-0074 ( Other Identifier: NIH )
75763 ( Other Identifier: Stanford IRB )
CA66785 ( Other Identifier: NIH )
First Posted: December 18, 2009    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases