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

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Genetic: proteomic profiling; Procedure: lumpectomy or mastectomy; Procedure: dynamic contrast-enhanced magnetic resonance imaging; Procedure: histopathologic examination; Procedure: magnetic resonance spectroscopy

• Registration Number: NCT00656604
• Lead Sponsor: Vanderbilt-Ingram Cancer Center

Brief 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.

Study Timeline

• Study Start: 2003-11
• Primary Completion: 2005-10
• Study Completion: 2008-01
• Study First Submitted: 2008-04-10
• Study First Submitted QC: 2008-04-10
• Study First Posted: 2008-04-11
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-04
• Last Update Posted: 2013-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Women with breast cancer	proteomic profiling	Patients undergo DCE-MRI and MRS prior to their breast cancer surgery.
Women with breast cancer	lumpectomy or mastectomy	Patients undergo DCE-MRI and MRS prior to their breast cancer surgery.
Women with breast cancer	dynamic contrast-enhanced magnetic resonance imaging	Patients undergo DCE-MRI and MRS prior to their breast cancer surgery.
Women with breast cancer	histopathologic examination	Patients undergo DCE-MRI and MRS prior to their breast cancer surgery.
Women with breast cancer	magnetic resonance spectroscopy	Patients undergo DCE-MRI and MRS prior to their breast cancer surgery.

Primary Outcome Measures

Name	Time	Method
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	At time of breast surgery	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

Name	Time	Method
Evaluation of the impact of MRS data on treatment planning for radiotherapy and/or surgery in women with breast cancer	After the last scan	Investigators will evaluate the effectiveness of spectroscopic data used to plan for the patient's post-imaging surgery and/or post-surgical radiotherapy.