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Magnetic Resonance Imaging of Breast Cancer
Conditions
Breast Cancer - Breast Cancer Non-invasive Breast Cancer
Conditions: official terms
Breast Neoplasms
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Intervention
Name: MRI
Type: Procedure
Overall Status
Recruiting
Summary
To compare magnetic resonance imaging (MRI) with more well established diagnostic imaging techniques to determine which method best finds and defines breast cancer.
Criteria for eligibility
Healthy Volunteers: Accepts Healthy Volunteers
Maximum Age: N/A
Minimum Age: 21 Years
Gender: Female
Criteria: 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.
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.
Location
Stanford University School of Medicine
Stanford, California, United States
Status: Recruiting
Contact: Sumita Sood - 650-723-0618 - ssood@stanford.edu
Start Date
April 1995
Completion Date
December 2016
Sponsors
Stanford University
Source
Stanford University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
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