Magnetic Resonance Imaging of Breast Cancer

This study is currently recruiting participants.
Verified October 2013 by Stanford University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01035112
First received: December 17, 2009
Last updated: October 29, 2013
Last verified: October 2013

December 17, 2009
October 29, 2013
April 1995
November 2013   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01035112 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Magnetic Resonance Imaging of Breast Cancer
Magnetic Resonance Imaging of Breast Cancer

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

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Breast Cancer
  • Breast Cancer Non-invasive Breast Cancer
Procedure: MRI
Experimental: MRI
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.
Intervention: Procedure: MRI
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
531
November 2013
November 2013   (final data collection date for primary outcome measure)

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.

Female
21 Years and older
Yes
Contact: Bruce Daniel (650) 498-6507 bdaniel@stanford.edu
United States
 
NCT01035112
BRSNSTU0004, 13IB-0074, 75763, SU-10312007-769, CA66785
Not Provided
Stanford University
Stanford University
National Institutes of Health (NIH)
Principal Investigator: Bruce Lewis Daniel Stanford University
Stanford University
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP