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

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
proteomic profiling
lumpectomy or mastectomy
dynamic contrast-enhanced magnetic resonance imaging
histopathologic examination
magnetic resonance spectroscopy
Sponsored by
Vanderbilt-Ingram Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Cancer focused on measuring recurrent breast cancer, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Women with breast cancer

    Healthy volunteers

    Arm Description

    Patients undergo DCE-MRI and MRS prior to their breast cancer surgery.

    Women without breast cancer undergo DCE-MRI and MRS.

    Outcomes

    Primary Outcome 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
    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 Outcome Measures

    Evaluation of the impact of MRS data on treatment planning for radiotherapy and/or surgery in women with breast cancer
    Investigators will evaluate the effectiveness of spectroscopic data used to plan for the patient's post-imaging surgery and/or post-surgical radiotherapy.

    Full Information

    First Posted
    April 10, 2008
    Last Updated
    March 4, 2013
    Sponsor
    Vanderbilt-Ingram Cancer Center
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00656604
    Brief Title
    Evaluation of Patients With Breast Cancer Using DCE-MRI, MRS, and Proteomics
    Official Title
    Evaluation of Patients With Breast Cancer Using Dynamic Contrast-Enhanced Magnetic Resonance Imaging, Magnetic Resonance Spectroscopy, and Proteomics
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2003 (undefined)
    Primary Completion Date
    October 2005 (Actual)
    Study Completion Date
    January 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Vanderbilt-Ingram Cancer Center
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Cancer
    Keywords
    recurrent breast cancer, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Women with breast cancer
    Arm Type
    Experimental
    Arm Description
    Patients undergo DCE-MRI and MRS prior to their breast cancer surgery.
    Arm Title
    Healthy volunteers
    Arm Type
    No Intervention
    Arm Description
    Women without breast cancer undergo DCE-MRI and MRS.
    Intervention Type
    Genetic
    Intervention Name(s)
    proteomic profiling
    Other Intervention Name(s)
    proteomic analysis
    Intervention Description
    at the time of each procedure.
    Intervention Type
    Procedure
    Intervention Name(s)
    lumpectomy or mastectomy
    Other Intervention Name(s)
    None noted
    Intervention Description
    removal of breast tumor or removal of the entire breast in which the tumor is located
    Intervention Type
    Procedure
    Intervention Name(s)
    dynamic contrast-enhanced magnetic resonance imaging
    Other Intervention Name(s)
    DCE-MRI
    Intervention Description
    Prior to initiation of treatment
    Intervention Type
    Procedure
    Intervention Name(s)
    histopathologic examination
    Other Intervention Name(s)
    Not noted
    Intervention Description
    After the breast tumor has been removed, examination of the tumor under a microscope to determine the type and grade of breast cancer
    Intervention Type
    Procedure
    Intervention Name(s)
    magnetic resonance spectroscopy
    Other Intervention Name(s)
    MRS
    Intervention Description
    Prior to initiation of treatment
    Primary Outcome Measure Information:
    Title
    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
    Description
    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.
    Time Frame
    At time of breast surgery
    Secondary Outcome Measure Information:
    Title
    Evaluation of the impact of MRS data on treatment planning for radiotherapy and/or surgery in women with breast cancer
    Description
    Investigators will evaluate the effectiveness of spectroscopic data used to plan for the patient's post-imaging surgery and/or post-surgical radiotherapy.
    Time Frame
    After the last scan

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    A. Bapsi Chakravarthy, MD
    Organizational Affiliation
    Vanderbilt-Ingram Cancer Center
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

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

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