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Non-Invasive Magnetic Resonance Imaging (MRI) and Magnetic Resonance Spectroscopy Techniques (MRS) for Assessing Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer
This study is ongoing, but not recruiting participants.
First Received: June 20, 2007   Last Updated: February 20, 2009   History of Changes
Sponsors and Collaborators: M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00490503
  Purpose

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

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer MRI Scans Surgery
U.S. FDA Resources
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

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • To study 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. [ Time Frame: 3 Years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Biospecimen Description:

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.

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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00490503

Locations
United States, Texas
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Gary Whitman, MD U.T.M.D. Anderson Cancer Center
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

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

Keywords provided by M.D. Anderson Cancer Center:
Breast Cancer
Magnetic Resonance Imaging
Magnetic Resonance Spectroscopy
DCE-MRI
 DW-MRI
MRS
MRI

Study placed in the following topic categories:
Skin Diseases
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Skin Diseases
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on May 07, 2009



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