Evaluation of Patients With Breast Cancer Using DCE-MRI, MRS, and Proteomics

Overview

RATIONALE: Diagnostic procedures, such as dynamic contrast-enhanced magnetic resonance imaging(DCE-MRI), magnetic resonance spectroscopy (MRS), and tissue proteomics, may help doctors find and diagnose breast cancer and plan the best treatment.

PURPOSE: This clinical trial is studying MRI and MRS with or without tissue proteomics analysis to see how well they work in evaluating healthy women and women who are undergoing surgery for breast cancer.

Full Title of Study: “Evaluation of Patients With Breast Cancer Using Dynamic Contrast-Enhanced Magnetic Resonance Imaging, Magnetic Resonance Spectroscopy, and Proteomics”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2005

Detailed Description

OBJECTIVES:

- To correlate data obtained by DCE-MRI and MRS in healthy women and in women who are undergoing surgery for breast cancer with data obtained by conventional X-ray mammography, tissue proteomics, and histopathology.

- To evaluate the impact of MRSI data on treatment planning for radiotherapy and/or surgery.

OUTLINE: Healthy participants undergo dynamic contrast-enhanced (DCE)-MRI and magnetic resonance spectroscopic (MRS) for longitudinal studies of breast imaging and spectroscopy.

Patients with breast cancers undergo DCE-MRI and MRS prior to initiation of treatment (i.e., surgery, chemotherapy, or radiotherapy). After treatment has begun, patients then undergo repeat imaging (not more than 1 per month) for follow-up assessments and longitudinal studies.

Breast tissue samples are collected from patients undergoing surgery. Samples are evaluated by histopathological and proteomic analysis for correlation with DCE-MRI and MRS findings.

The study interventions are discontinued after definitive surgery is performed.

PROJECTED ACCRUAL: A total of 10 healthy participants and 40 patients with breast cancer will be accrued for this study.

Interventions

  • Genetic: proteomic profiling
    • at the time of each procedure.
  • Procedure: lumpectomy or mastectomy
    • removal of breast tumor or removal of the entire breast in which the tumor is located
  • Procedure: dynamic contrast-enhanced magnetic resonance imaging
    • Prior to initiation of treatment
  • Procedure: histopathologic examination
    • After the breast tumor has been removed, examination of the tumor under a microscope to determine the type and grade of breast cancer
  • Procedure: magnetic resonance spectroscopy
    • Prior to initiation of treatment

Arms, Groups and Cohorts

  • Experimental: Women with breast cancer
    • Patients undergo DCE-MRI and MRS prior to their breast cancer surgery.
  • No Intervention: Healthy volunteers
    • Women without breast cancer undergo DCE-MRI and MRS.

Clinical Trial Outcome Measures

Primary Measures

  • Correlation of data obtained by DCE-MRI and magnetic resonance spectroscopy (MRS) with data obtained by conventional X-ray mammography, tissue proteomics, and histopathology in women with breast cancer
    • Time Frame: At time of breast surgery
    • Imaging and spectroscopic studies are performed before surgery. After surgery, this data will be compared and contrast with data obtained from conventional mammograms and the patient’s tissue.

Secondary Measures

  • Evaluation of the impact of MRS data on treatment planning for radiotherapy and/or surgery in women with breast cancer
    • Time Frame: After the last scan
    • Investigators will evaluate the effectiveness of spectroscopic data used to plan for the patient’s post-imaging surgery and/or post-surgical radiotherapy.

Participating in This Clinical Trial

DISEASE CHARACTERISTICS:

  • Meets 1 of the following criteria:
  • Women with breast tumors planning to undergo surgical resection
  • Healthy volunteers, including any constitutionally healthy female with no history of breast cancer
  • Hormone receptor status not specified

PATIENT CHARACTERISTICS:

  • Female
  • Menopausal status not specified
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Not acutely ill
  • No non-magnetic resonance-compatible ferromagnetic materials present in the body

PRIOR CONCURRENT THERAPY:

  • Prior chemotherapy and/or radiotherapy allowed

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Vanderbilt-Ingram Cancer Center
  • Collaborator
    • National Cancer Institute (NCI)
  • Provider of Information About this Clinical Study
    • Principal Investigator: A Bapsi Chakravarthy, MD, Associate Professor – Vanderbilt-Ingram Cancer Center
  • Overall Official(s)
    • A. Bapsi Chakravarthy, MD, Study Chair, Vanderbilt-Ingram Cancer Center

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