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Magnetic Resonance Imaging of Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by Stanford University
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01035112
First received: December 17, 2009
Last updated: July 7, 2016
Last verified: July 2016

December 17, 2009
July 7, 2016
April 1995
December 2016   (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
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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
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
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.
  • Breast Cancer
  • Breast Cancer Non-invasive Breast Cancer
Procedure: MRI
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
445
December 2016
December 2016   (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   (Adult, Senior)
Yes
United States
 
NCT01035112
BRSNSTU0004, 13IB-0074, 75763, SU-10312007-769, CA66785
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Stanford University
Stanford University
National Institutes of Health (NIH)
Principal Investigator: Bruce Lewis Daniel Stanford University
Stanford University
July 2016

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