Breast MRI Spectroscopy

Not Applicable

Completed

• Conditions: Suspicion of, or Known Breast Cancer
• Interventions: Other: Radiology/MRI scan

• Registration Number: NCT00577915
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2003-05
• Study First Submitted: 2007-12-18
• Study First Submitted QC: 2007-12-19
• Study First Posted: 2007-12-20
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-28
• Last Update Posted: 2016-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

• Scheduled for diagnostic breast MRI examination or interventional procedure for a known or suspected breast lesion

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Breast MR Spectroscopy	Radiology/MRI scan	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.

Primary Outcome Measures

Name	Time	Method
To determine if spectroscopy of the breast can be performed and can be functional in a clinical environment.	12 months

Secondary Outcome Measures

Name	Time	Method
To determine if the data obtained can be reliably analyzed and useful to the final interpretation of the breast MRI examination.	12 months

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States