Magnetic Resonance Imaging of Breast Cancer
| Tracking Information | |||||
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| First Received Date ICMJE | December 17, 2009 | ||||
| Last Updated Date | December 5, 2012 | ||||
| Start Date ICMJE | April 1995 | ||||
| Estimated Primary Completion Date | November 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01035112 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Magnetic Resonance Imaging of Breast Cancer | ||||
| Official Title ICMJE | Magnetic Resonance Imaging of Breast Cancer | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
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| Condition ICMJE |
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| Intervention ICMJE | Procedure: MRI | ||||
| Study Arm (s) | 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 |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 531 | ||||
| Estimated Completion Date | November 2013 | ||||
| Estimated Primary Completion Date | November 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | 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. |
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| Gender | Female | ||||
| Ages | 21 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01035112 | ||||
| Other Study ID Numbers ICMJE | BRSNSTU0004, 13IB-0074, 75763, SU-10312007-769, CA66785 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Stanford University | ||||
| Study Sponsor ICMJE | Stanford University | ||||
| Collaborators ICMJE | National Institutes of Health (NIH) | ||||
| Investigators ICMJE |
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| Information Provided By | Stanford University | ||||
| Verification Date | December 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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