Breast MRI Spectroscopy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Breast MRI Spectroscopy

Conditions
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Suspicion of, or Known Breast Cancer

Intervention / Treatment
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* Other: Radiology/MRI scan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Scheduled for diagnostic breast MRI examination or interventional procedure for a known or suspected breast lesion Exclusion Criteria: Patients who would be normally excluded from undergoing an MRI examination: Patients with a pacemaker, aneurysm clip or any other condition that would warrant avoidance of a strong magnetic field
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Breast MR Spectroscopy<br>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<br>* MRI spectroscopy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine if spectroscopy of the breast can be performed and can be functional in a clinical environment. |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine if the data obtained can be reliably analyzed and useful to the final interpretation of the breast MRI examination. |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast cancer, MRI spectroscopy, Diagnostic radiology