NCT00656604

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Vanderbilt-Ingram Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
GENETIC	proteomic profiling	at the time of each procedure.
PROCEDURE	lumpectomy or mastectomy	removal of breast tumor or removal of the entire breast in which the tumor is located
PROCEDURE	dynamic contrast-enhanced magnetic resonance imaging	Prior to initiation of treatment
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
PROCEDURE	magnetic resonance spectroscopy	Prior to initiation of treatment

Timeline

• Start date: 2003-11-01
• Primary completion: 2005-10-01
• Completion: 2008-01-01
• First posted: 2008-04-11
• Last updated: 2013-03-05