Non-Invasive MRI and MRS Techniques for Assessing Therapeutic Response to Pre-surgical Chemotherapy in Breast Cancer Patients
In this study, MRI will be used to determine the effects of pre-surgical chemotherapy on
breast cancer. MRS looks at the chemical components of tissue. MRS may be helpful in
understanding how pre-surgical chemotherapy works.
Before you can start treatment on this study, you will have "screening tests." These tests
will help the doctor decide if you are eligible to take part in this study. Blood (about 1
teaspoon) will be drawn for routine tests. Women who are able to have children must have a
negative blood (about 1 teaspoon) pregnancy test.
If you are found to be eligible to take part in this study, you will have 3 MRI with MRS
scans on both breast including the affected breast. The scans will be performed before
chemotherapy, 21 days (plus or minus 3 days) after you start chemotherapy (Day 1 = your
first day of chemotherapy), and at the end of the chemotherapy/before surgery. If you
have never had an MRI scan before, you will be given the opportunity to watch a 10-minute
video to prepare you for the procedure.
You will have specialized MRI scans: MRS, DCE, and DW. The DCE is a Dynamic Contrast
Enhanced MRI. DCE-MRI is used to create a 3-D image of the breast tumor, so that the
small blood vessels can be seen. The Diffusion-Weighted (DW) MRI may possibly be used to
study the structure of tumor cells based on the movement of water molecules in tumor
For this, you will lie still on your stomach with your breasts positioned within the
openings of the detector. A contrast drug, which helps the MRI scanner to show the breast
lesion, will be injected through a needle in your vein. The procedure will take about 1
The tissues removed during the surgery will be collected as part of this study. Small
pieces of tissues will be stained with special stains to give more information about the
tumor (such as invasiveness, blood vessel supply, number of positive lymph nodes, tissue
changes). Multiple sections of the tissues will be stained to make sure that all tissue
areas of interest will be able to be compared with MRI/MRS images. The tissues then will be
photographed and x-rayed.
You will be considered off-study 6 months after surgery. If you are unable to have surgery,
you will be considered off-study 6 months after the last MRI with MRS.
This is an investigational study. The MRI with MRS scans are FDA approved and commercially
available. The first and third scans will be part of routine patient care. The second scan
is not part of routine care. Up to 28 participants will take part in this study. All will
be enrolled at M. D. Anderson.
Observational Model: Case-Only, Time Perspective: Prospective
Individual Analyses between Quantitative MR Measures + Pathologic Outcome Measures
Quantitative measures of tissue function obtained non-invasively by dynamic contrast enhanced (DCE) MRI, diffusion-weighted (DW) MRI, and proton MR spectroscopy (1H MRS) techniques to assess effects of pre-surgical chemotherapy in breast cancer patients eligible for preoperative chemotherapy.
Before chemotherapy, 21 ± 3 days after the initiation of chemotherapy (day 1 = first day of chemotherapy), and at end of chemotherapy and prior to any surgery.
Gary Whitman, MD
M.D. Anderson Cancer Center
United States: Institutional Review Board
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