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
  Purpose

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.


Condition Intervention
Breast Cancer
Genetic: proteomic profiling
Procedure: lumpectomy or mastectomy
Procedure: dynamic contrast-enhanced magnetic resonance imaging
Procedure: histopathologic examination
Procedure: magnetic resonance spectroscopy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Evaluation of Patients With Breast Cancer Using Dynamic Contrast-Enhanced Magnetic Resonance Imaging, Magnetic Resonance Spectroscopy, and Proteomics

Resource links provided by NLM:


Further study details as provided by Vanderbilt-Ingram Cancer Center:

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 [ 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.


Secondary Outcome 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 ] [ 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.


Enrollment: 30
Study Start Date: November 2003
Study Completion Date: January 2008
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Women with breast cancer
Patients undergo DCE-MRI and MRS prior to their breast cancer surgery.
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
No Intervention: Healthy volunteers
Women without breast cancer undergo DCE-MRI and MRS.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00656604

Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
Investigators
Study Chair: A. Bapsi Chakravarthy, MD Vanderbilt-Ingram Cancer Center
  More Information

No publications provided

Responsible Party: A Bapsi Chakravarthy, MD, Associate Professor, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT00656604     History of Changes
Other Study ID Numbers: VICC BRE 0358, P30CA068485, VU-VICC-BRE-0358, VU-VICC-IRB-030472
Study First Received: April 10, 2008
Last Updated: March 4, 2013
Health Authority: United States: Federal Government

Keywords provided by Vanderbilt-Ingram Cancer Center:
recurrent breast cancer
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer

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

ClinicalTrials.gov processed this record on September 22, 2014