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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00656604
• Other study ID #: VICC BRE 0358
• Secondary ID: P30CA068485VU-VI
• Status: Completed
• Phase: N/A
• First received: April 10, 2008
• Last updated: March 4, 2013
• Start date: November 2003
• Est. completion date: January 2008

Study information

• Verified date: March 2013
• Source: Vanderbilt-Ingram Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2008
• Est. primary completion date: October 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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
• dynamic contrast-enhanced magnetic resonance imaging
Prior to initiation of treatment
• 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
• magnetic resonance spectroscopy
Prior to initiation of treatment

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt-Ingram Cancer Center	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	At time of breast surgery	No
Secondary	Evaluation of the impact of MRS data on treatment planning for radiotherapy and/or surgery in women with breast cancer	Investigators will evaluate the effectiveness of spectroscopic data used to plan for the patient's post-imaging surgery and/or post-surgical radiotherapy.	After the last scan	No