Magnetic Resonance Imaging of Breast Cancer
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Purpose
To compare magnetic resonance imaging (MRI) with more well established diagnostic imaging techniques to determine which method best finds and defines breast cancer.
| Condition | Intervention |
|---|---|
|
Breast Cancer Breast Cancer Non-invasive Breast Cancer |
Procedure: MRI |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | 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. [ Time Frame: Length of one MRI scan ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 531 |
| Study Start Date: | April 1995 |
| Estimated Study Completion Date: | November 2013 |
| Estimated Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Procedure: MRI |
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations| Contact: Bruce Daniel | (650) 498-6507 | bdaniel@stanford.edu |
| United States, California | |
| Stanford University School of Medicine | Recruiting |
| Stanford, California, United States, 94305 | |
| Contact: Bruce Daniel 650-498-6507 bdaniel@stanford.edu | |
| Contact: Cancer Clinical Trials Office (650) 498-7061 | |
| Principal Investigator: Bruce Lewis Daniel | |
| Sub-Investigator: Brian Andrew Hargreaves | |
| Sub-Investigator: Robert J Herfkens | |
| Principal Investigator: | Bruce Lewis Daniel | Stanford University |
More Information
No publications provided
| Responsible Party: | Stanford University |
| ClinicalTrials.gov Identifier: | NCT01035112 History of Changes |
| Other Study ID Numbers: | BRSNSTU0004, 13IB-0074, 75763, SU-10312007-769, CA66785 |
| Study First Received: | December 17, 2009 |
| Last Updated: | December 5, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on May 23, 2013