Breast MRI Spectroscopy

NCT ID: NCT00577915

Last Updated: 2016-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-05-31

Study Completion Date

2016-06-30

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.

Conditions

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Suspicion of, or Known Breast Cancer

Keywords

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Breast cancer MRI spectroscopy Diagnostic radiology

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Radiology/MRI scan

Intervention Type OTHER

MRI spectroscopy

Interventions

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Radiology/MRI scan

MRI spectroscopy

Intervention Type OTHER

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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sandra Brennan, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

Countries

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United States

Related Links

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http://www.mskcc.org

Memorial Sloan Kettering Cancer Center

Other Identifiers

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03-037

Identifier Type: -

Identifier Source: org_study_id