Breast MRI Spectroscopy, Department of Defense (DOD)
May 9, 2013 updated by: Memorial Sloan Kettering Cancer Center
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Observational
Enrollment (Actual)
146
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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New York, New York, United States, 10065
- Memorial Sloan-Kettering Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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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
|
conclusion of study
|
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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
|
conclusion of study
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
conclusion of study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Sandra Brennan, MD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2006
Primary Completion (Actual)
May 1, 2013
Study Completion (Actual)
May 1, 2013
Study Registration Dates
First Submitted
December 21, 2007
First Submitted That Met QC Criteria
December 21, 2007
First Posted (Estimate)
December 28, 2007
Study Record Updates
Last Update Posted (Estimate)
May 13, 2013
Last Update Submitted That Met QC Criteria
May 9, 2013
Last Verified
May 1, 2013
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 05-101
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.