Non-Invasive MRI and MRS Techniques for Assessing Therapeutic Response to Pre-surgical Chemotherapy in Breast Cancer Patients
18 Years
N/A
Both
Breast Cancer
Trial Information
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
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.
Inclusion Criteria:
1. Patients with newly diagnosed stage II A-B or III A-C breast cancers who are
scheduled to start systemic chemotherapy.
2. Patients must have a histological diagnosis of invasive breast cancer.
3. Patients whose extent of disease is determined by physical examination and
conventional imaging (mammography and sonography).
4. Patients should have not received any previous chemotherapy for their newly diagnosed
Stage II A-B or III A-C breast cancer.
5. Patients must be age 18 or older.
6. ECOG performance status 0-2.
7. Patients with history of prior malignancies must be disease-free for at least 5 years
prior of study entry.
8. Normal hematological function: WBC > 3000/ul, absolute neutrophil count > 1500/ul,
platelets > 100,000/ul, and Hgb > 10 gms (transfusion to achieve Hgb > 10 gms is
acceptable).
9. Serum total bilirubin < 1.5 mg/dl and SGPT < 1.5 X normal.
10. Patients must sign an informed consent indicating that they are aware of the
investigational nature of the study in keeping with the policies of the hospital. The
only acceptable consent form is the one attached at the end of this protocol.
Exclusion Criteria:
1. Patients who received previous chemotherapy for the newly diagnosed breast cancer.
2. Patients with no evidence of primary breast lesion (e.g., T0, Tx).
3. Patients who are unwilling to come back for regular assessments of response.
4. Patients with claustrophobia or obesity (exceeding the equipment weight limits).
5. Pregnant women, lactating women or sexually active women of childbearing potential
who are not practicing adequate contraception.
6. Patients with myocardial infarction within 6 months of study entry; unstable angina
pectoris; uncontrolled congestive heart failure; uncontrolled arrhythmias.
7. Patients with pacemakers or other metallic inserts that are not compatible with 3-T
MR scanners.
8. Patients with bilateral breast disease, and recurrent newly diagnosed breast cancer.
Type of Study:
Observational
Study Design:
Observational Model: Case-Only, Time Perspective: Prospective
Outcome Measure:
Individual Analyses between Quantitative MR Measures + Pathologic Outcome Measures
Outcome Description:
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.
Outcome 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.
Safety Issue:
No
Principal Investigator
Gary Whitman, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
M.D. Anderson Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
2006-0501
NCT ID:
NCT00490503
Start Date:
October 2006
Completion Date:
Related Keywords:
- Breast Cancer
- Breast Cancer
- Magnetic Resonance Imaging
- Magnetic Resonance Spectroscopy
- DCE-MRI
- DW-MRI
- MRS
- MRI
- Breast Neoplasms
Name | Location |
|---|---|
| UT MD Anderson Cancer Center | Houston, Texas 77030 |
