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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center Department of Defense |
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Information provided by: | Memorial Sloan-Kettering Cancer Center |
ClinicalTrials.gov Identifier: | NCT00582569 |
The purpose of this new imaging method is to provide physicians with additional information not available with standard imaging methods. This includes information about the make up of different breast diseases. Using spectroscopy data, it may be possible to tell the difference between benign conditions of the breast from malignant tumors and provide more accurate information than can be obtained with regular MRI. Along with the MRI a new method of evaluating the images or pictures will be used. This new method is called spectroscopy and is used routinely on other parts of the body such as the prostate and brain. Pictures produced with this sequence look different than the regular MRI pictures. Performing spectroscopy on a 1.5T magnet adds another imaging sequence (another scan) to the routine MRI protocol, thus increasing exam time (extra 10-15 minutes). This study will enroll patients who are scheduled for a Magnetic Resonance Imaging (MRI) examination ordered by their primary physician.
Condition |
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Breast Lesion |
Study Type: | Observational |
Study Design: | Case-Only, Prospective |
Official Title: | Breast MRI Spectroscopy, Department of Defense (DOD) |
Estimated Enrollment: | 150 |
Study Start Date: | February 2006 |
Estimated Study Completion Date: | February 2010 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
Our aim is to perform MR Spectroscopy (MRS) on 150 patients at the end of their clinically indicated routine breast MRI guided biopsy and breast MRI guided needle localization examination using a software package from General Electric Medical Systems (Milwaukee,WI). This will add time to the routine examination but will not involve additional injections of contrast. We will analyze the spectroscopic data to determine if benign lesions can be reliably differentiated from malignant ones. The MR Spectroscopy (MRS) will be administered at Memorial Sloan Kettering Cancer Center, 1275 York Ave, NY,NY 10021.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Include women with lesions, > or = to 1 centimeter that will undergo a diagnostic MRI exam, an MRI guided biopsy, or an MRI guided needle localization, such as women with breast cancer or women with clinical and/or mammographic findings suspicious for breast masses. However, any known breast lesion, benign or malignant, will be appropriate for evaluation with MR spectroscopy.
Inclusion Criteria:
Exclusion Criteria:
Contact: Sandra Brennan, MD | brennans@mskcc.org |
United States, New York | |
Memorial Sloan-Kettering Cancer Center | Recruiting |
New York, New York, United States, 10065 | |
Contact: Sandra Brennan brennans@mskcc.org |
Principal Investigator: | Sandra Brennan, MD | Memorial Sloan-Kettering Cancer Center |
Responsible Party: | Memorial Sloan-Kettering Cancer Center ( Sandra Brennan, MD ) |
Study ID Numbers: | 05-101 |
Study First Received: | December 21, 2007 |
Last Updated: | March 11, 2009 |
ClinicalTrials.gov Identifier: | NCT00582569 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Breast lesion Spectroscopy MRI |