Breast MRI Spectroscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00577915
Recruitment Status : Completed
First Posted : December 20, 2007
Last Update Posted : November 29, 2016
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Suspicion of, or Known Breast Cancer Other: Radiology/MRI scan Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Breast MRI Spectroscopy
Study Start Date : May 2003
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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
MRI spectroscopy

Primary Outcome Measures :
  1. To determine if spectroscopy of the breast can be performed and can be functional in a clinical environment. [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00577915

United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Principal Investigator: Sandra Brennan, MD Memorial Sloan Kettering Cancer Center

Additional Information:
Responsible Party: Memorial Sloan Kettering Cancer Center Identifier: NCT00577915     History of Changes
Other Study ID Numbers: 03-037
First Posted: December 20, 2007    Key Record Dates
Last Update Posted: November 29, 2016
Last Verified: November 2016

Keywords provided by Memorial Sloan Kettering Cancer Center:
Breast cancer
MRI spectroscopy
Diagnostic radiology