Non-Invasive Magnetic Resonance Imaging (MRI) and Magnetic Resonance Spectroscopy Techniques (MRS) for Assessing Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer
The goal of this clinical research study is to learn if magnetic resonance imaging (MRI) with magnetic resonance spectroscopy (MRS) can show the effects of pre-surgical chemotherapy in breast cancer patients who are eligible to receive preoperative chemotherapy.
Procedure: Magnetic Resonance Imaging (MRI)
Procedure: Magnetic Resonance Spectroscopy (MRS)
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Non-Invasive MRI and MRS Techniques for Assessing Therapeutic Response to Pre-surgical Chemotherapy in Breast Cancer Patients|
- Individual Analyses between Quantitative MR Measures + Pathologic Outcome Measures [ Time Frame: 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. ] [ Designated as safety issue: No ]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.
Biospecimen Retention: Samples Without DNA
The tissues removed during surgery (mastectomy) will be collected as part of this study.
|Study Start Date:||October 2006|
|Estimated Primary Completion Date:||October 2016 (Final data collection date for primary outcome measure)|
MRI + MRS
Patients with newly diagnosed stage II A-B or III A-C breast cancers who are scheduled to start systemic chemotherapy.
Procedure: Magnetic Resonance Imaging (MRI)
3 Scans performed before chemotherapy, 21 days (plus or minus 3 days) after start chemotherapy (Day 1 = your first day of chemotherapy), and at end of chemotherapy/before surgery.
Other Name: MRIProcedure: Magnetic Resonance Spectroscopy (MRS)
3 MRI Scans with MRS performed before chemotherapy, 21 days (plus or minus 3 days) after start chemotherapy (Day 1 = your first day of chemotherapy), and at end of chemotherapy/before surgery.
Other Name: MRS
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 tissue.
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 hour.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00490503
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Gary Whitman, MD||M.D. Anderson Cancer Center|