Breast MRI Spectroscopy
The purpose of this study is to provide physicians with additional information not available with standard imaging methods for breast disease.
As part of the MRI examination ordered by your physician, a new method of analyzing 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 may look slightly different than the regular MRI pictures. Using spectroscopy data, it may be possible to distinguish benign conditions of the breast from malignant tumors and provide more precise information than can be obtained with regular MRI.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Breast MRI Spectroscopy|
- To determine if spectroscopy of the breast can be performed and can be functional in a clinical environment. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- To determine if the data obtained can be reliably analyzed and useful to the final interpretation of the breast MRI examination. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
|Study Start Date:||May 2003|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Experimental: Breast MR Spectroscopy
Conventional images will be taken with standard pulse sequences. These images will be used for the diagnostic examination for which the patient will have been scheduled. Following the diagnostic study, a pulse sequence designed to obtain spectroscopy data will be used.This will be used on the existing magnets 1.5T and 3T. Memorial Sloan-Kettering Cancer Center has 1.5T and 3T magnets. The patient will have only one injection of contrast (gadolinium-DTPA) for the initial diagnostic study. No additional contrast will be administered. The additional sequence should take about 10 minutes, depending on breast size.
Other: Radiology/MRI scan
Our aim is to perform MR Spectroscopy (MRS) on 150 evaluable patients at the end of their routine breast MRI 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00577915
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Sandra Brennan, MD||Memorial Sloan Kettering Cancer Center.|