Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
M.D. Anderson Cancer Center National Cancer Institute (NCI) |
---|---|
Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00490503 |
The overall goal of this proposed pilot study is to validate, based on tissue-based 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 for assessing the effects of pre-surgical chemotherapy in breast cancer patients who are eligible to receive preoperative chemotherapy.
The specific aims of this project are: (1) to incorporate DCE-MRI, DW-MRI, and MRS techniques and analysis tools into the clinical MRI exam to determine longitudinal changes in permeability, cellularity and metabolism in breast tumors of breast cancer patients undergoing pre-surgical chemotherapy; and (2) to compare quantitative MR measurements from patients with histopathological and immunohistochemical (IHC) findings from mastectomy and segmental mastectomy specimens.
Condition | Intervention |
---|---|
Breast Cancer |
Procedure: Magnetic Resonance Imaging Procedure: Magnetic Resonance Spectroscopy |
Study Type: | Observational |
Study Design: | Case-Only, Prospective |
Official Title: | Non-Invasive MRI and MRS Techniques for Assessing Therapeutic Response to Pre-Surgical Chemotherapy in Breast Cancer Patients |
The tissues removed during surgery (mastectomy) will be collected as part of this study.
Estimated Enrollment: | 20 |
Study Start Date: | October 2006 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
---|---|
1
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
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.
Procedure: Magnetic Resonance Spectroscopy
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.
|
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 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.
For each MRI scan with MRS, you will lie still on your stomach with your breasts positioned within the openings of the detector. A contrast agent, which helps to detect the breast lesion, will be given through a needle in your vein. The procedure will take about 1 hour.
After the completion of pre-surgical chemotherapy, you will have either a mastectomy or breast saving surgery. Your doctor will discuss the surgery in more detail with you and you will be consented separately.
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 A 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.
Up to 20 participants will take part in this study. All will be enrolled at M. D. Anderson.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Patients with newly diagnosed stage II A-B or III A-C breast cancers who are scheduled to start systemic chemotherapy.
Inclusion Criteria:
Exclusion Criteria:
United States, Texas | |
U.T.M.D. Anderson Cancer Center | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Gary Whitman, MD | U.T.M.D. Anderson Cancer Center |
Responsible Party: | U.T.M.D. Anderson Cancer Center ( Gary Whitman, MD/Associate Professor ) |
Study ID Numbers: | 2006-0501 |
Study First Received: | June 20, 2007 |
Last Updated: | February 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00490503 History of Changes |
Health Authority: | United States: Institutional Review Board |
Breast Cancer Magnetic Resonance Imaging Magnetic Resonance Spectroscopy DCE-MRI |
DW-MRI MRS MRI |
Skin Diseases Breast Neoplasms Breast Diseases |
Neoplasms Neoplasms by Site Skin Diseases Breast Neoplasms Breast Diseases |