The purpose of this study is to investigate the use of intra-operative Magnetic Resonance Imaging (MRI) and Mass Spectrometry (MS) during breast conserving surgery, and to determine if these tests are capable of accurately predicting the presence or absence of breast tumor in surgical specimens at the margins.
This research study is a Phase II clinical trial investigating the use of intra-operative MRI and MS in breast cancer surgery. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied. Prior research has shown that intraoperative MRI and MS are two types of tests that are feasible to use during cancer surgery and may be able to guide therapy. In this study, we are evaluating the accuracy of intra-operative MRI and MS in determining whether or not all cancer tissue was removed during breast surgery.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
40
Analysis of Tissue Sample
Brigham and Women's Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
To evaluate the accuracy of MRI in detecting tumor boundaries
Time frame: 2 Years
To determine the operating characteristics (sensitivity, specificity, negative predictive value and positive predictive value) of MRI in detecting tumor boundaries as confirmed with pathologic results
Time frame: 2 Years
To evaluate the correlation of intraoperative mass spectrometry results to tumor boundaries as confirmed with pathologic results.
Time frame: 2 Years
To develop novel image processing algorithms to detect remnant tumor from intraoperative DCE-MRI in presence of tissue edema and reduced perfusion
Time frame: 2 Years
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