Clinical trial NCT00490503: Non-Invasive Magnetic Resonance Imaging (MRI) and Magnetic Resonance Spectroscopy Techniques (MRS) for Assessing Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer
Official title: Non-Invasive MRI and MRS Techniques for Assessing Therapeutic Response to Pre-surgical Chemotherapy in Breast Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Breast Cancer
Magnetic Resonance Imaging
Magnetic Resonance Spectroscopy
DCE-MRI
DW-MRI
MRS
MRI
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-06-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with newly diagnosed stage II A-B or III A-C breast cancers who are scheduled to start systemic chemotherapy.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Individual Analyses between Quantitative MR Measures + Pathologic Outcome Measures
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Gary Whitman, MD
role: PRINCIPAL_INVESTIGATOR
References: