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Breast MRI Spectroscopy, Department of Defense (DOD)

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: NCT00582569
Recruitment Status : Completed
First Posted : December 28, 2007
Last Update Posted : May 13, 2013
United States Department of Defense
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief Summary:
The purpose of this new imaging method is to provide physicians with additional information not available with standard imaging methods. This includes information about the make up of different breast diseases. Using spectroscopy data, it may be possible to tell the difference between benign conditions of the breast from malignant tumors and provide more accurate information than can be obtained with regular MRI. Along with the MRI a new method of evaluating 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 look different than the regular MRI pictures. Performing spectroscopy on a 1.5T magnet adds another imaging sequence (another scan) to the routine MRI protocol, thus increasing exam time (extra 10-15 minutes). This study will enroll patients who are scheduled for a Magnetic Resonance Imaging (MRI) examination ordered by their primary physician.

Condition or disease
Breast Lesion

Detailed Description:
Our aim is to perform MR Spectroscopy (MRS) on 150 patients at the end of their clinically indicated routine breast MRI guided biopsy and breast MRI guided needle localization 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. The MR Spectroscopy (MRS) will be administered at Memorial Sloan Kettering Cancer Center, 1275 York Ave, NY,NY 10021.

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Study Type : Observational
Actual Enrollment : 146 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Breast MRI Spectroscopy, Department of Defense (DOD)
Study Start Date : February 2006
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Primary Outcome Measures :
  1. to determine if spectroscopy of the breast can be performed and can be functional in a clinical environment for breast lesions _> 1centimeter [ Time Frame: conclusion of study ]
  2. To see if MRS can differentiate ben vs mal breast tissue with adequate specificity & sensitivity to be useful in clinical management. [ Time Frame: conclusion of study ]

Secondary Outcome Measures :
  1. if the data obtained can differentiate among various histologic subtypes of invasive and non-invasive breast cancers, and can be reliably analyzed and be useful to the final interpretation of the breast MRI examination. [ Time Frame: conclusion of study ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Include women with lesions, > or = to 1 centimeter that will undergo a diagnostic MRI exam, an MRI guided biopsy, or an MRI guided needle localization, such as women with breast cancer or women with clinical and/or mammographic findings suspicious for breast masses. However, any known breast lesion, benign or malignant, will be appropriate for evaluation with MR spectroscopy.

Inclusion Criteria:

  • Patient needs to be ≥ or = to 18 years of age
  • scheduled for diagnostic breast MRI examination or interventional procedure for a suspected or known breast lesion ≥ or = to 1 centimeter

Exclusion Criteria:

  • Patients who would be normally excluded from undergoing an MRI examination include:
  • Patients with a pacemaker, aneurysm clip or any other condition that would warrant avoidance of a strong magnetic field
  • Patients who are pregnant are excluded from participation of this study
  • Patients who are unable to comply or complete the MRI exam due to claustrophobia or high levels of anxiety.
  • Patients undergoing chemotherapy

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): NCT00582569

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United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
United States Department of Defense
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Principal Investigator: Sandra Brennan, MD Memorial Sloan Kettering Cancer Center
Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center Identifier: NCT00582569    
Other Study ID Numbers: 05-101
First Posted: December 28, 2007    Key Record Dates
Last Update Posted: May 13, 2013
Last Verified: May 2013
Keywords provided by Memorial Sloan Kettering Cancer Center:
Breast lesion