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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
A Bapsi Chakravarthy, MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:
NCT00656604
First received: April 10, 2008
Last updated: March 4, 2013
Last verified: March 2013

April 10, 2008
March 4, 2013
November 2003
October 2005   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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.
  • Correlation of data obtained by DCE-MRI and magnetic resonance spectroscopic imaging (MRSI) with data obtained by conventional X-ray mammography, tissue proteomics, and histopathology [ Designated as safety issue: No ]
  • Evaluation of the impact of MRSI data on treatment planning for radiotherapy and/or surgery [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00656604 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Investigators will evaluate the effectiveness of spectroscopic data used to plan for the patient's post-imaging surgery and/or post-surgical radiotherapy.
Not Provided
Not Provided
Not Provided
 
Evaluation of Patients With Breast Cancer Using DCE-MRI, MRS, and Proteomics
Evaluation of Patients With Breast Cancer Using Dynamic Contrast-Enhanced Magnetic Resonance Imaging, Magnetic Resonance Spectroscopy, and Proteomics

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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Breast Cancer
  • Genetic: proteomic profiling
    at the time of each procedure.
    Other Name: proteomic analysis
  • Procedure: lumpectomy or mastectomy
    removal of breast tumor or removal of the entire breast in which the tumor is located
    Other Name: None noted
  • Procedure: dynamic contrast-enhanced magnetic resonance imaging
    Prior to initiation of treatment
    Other Name: DCE-MRI
  • 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
    Other Name: Not noted
  • Procedure: magnetic resonance spectroscopy
    Prior to initiation of treatment
    Other Name: MRS
  • Experimental: Women with breast cancer
    Patients undergo DCE-MRI and MRS prior to their breast cancer surgery.
    Interventions:
    • Genetic: proteomic profiling
    • Procedure: lumpectomy or mastectomy
    • Procedure: dynamic contrast-enhanced magnetic resonance imaging
    • Procedure: histopathologic examination
    • Procedure: magnetic resonance spectroscopy
  • No Intervention: Healthy volunteers
    Women without breast cancer undergo DCE-MRI and MRS.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
January 2008
October 2005   (final data collection date for primary outcome measure)

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
Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00656604
VICC BRE 0358, P30CA068485, VU-VICC-BRE-0358, VU-VICC-IRB-030472
Yes
A Bapsi Chakravarthy, MD, Vanderbilt-Ingram Cancer Center
Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
Study Chair: A. Bapsi Chakravarthy, MD Vanderbilt-Ingram Cancer Center
Vanderbilt-Ingram Cancer Center
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP