Know Cancer

or
forgot password

Evaluation of Patients With Breast Cancer Using Dynamic Contrast-Enhanced Magnetic Resonance Imaging, Magnetic Resonance Spectroscopy, and Proteomics


N/A
18 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

Evaluation of Patients With Breast Cancer Using Dynamic Contrast-Enhanced Magnetic Resonance Imaging, Magnetic Resonance Spectroscopy, and Proteomics


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

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

Outcome 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.

Outcome Time Frame:

At time of breast surgery

Safety Issue:

No

Principal Investigator

A. Bapsi Chakravarthy, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Vanderbilt-Ingram Cancer Center

Authority:

United States: Federal Government

Study ID:

VICC BRE 0358

NCT ID:

NCT00656604

Start Date:

November 2003

Completion Date:

January 2008

Related Keywords:

  • Breast Cancer
  • recurrent breast cancer
  • stage I breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • Breast Neoplasms

Name

Location