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

Vanderbilt University Medical Center

Status: Completed

Conditions: Breast Cancer

Treatments: Procedure: dynamic contrast-enhanced magnetic resonance imaging; Genetic: proteomic profiling; Procedure: magnetic resonance spectroscopy; Procedure: histopathologic examination; Procedure: lumpectomy or mastectomy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00656604

VICC BRE 0358

P30CA068485 (U.S. NIH Grant/Contract)

VU-VICC-IRB-030472

VU-VICC-BRE-0358

Details and patient eligibility

About

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 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.

Enrollment: 30 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Women with breast cancer

Experimental group

Description:

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

Treatment:

Procedure: lumpectomy or mastectomy

Procedure: histopathologic examination

Procedure: magnetic resonance spectroscopy

Procedure: dynamic contrast-enhanced magnetic resonance imaging

Genetic: proteomic profiling

Healthy volunteers

No Intervention group

Description:

Women without breast cancer undergo DCE-MRI and MRS.