NCT00656604

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Nov 2003

Typical duration for not_applicable breast-cancer

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2005

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 11, 2008

Completed
Last Updated

March 5, 2013

Status Verified

March 1, 2013

Enrollment Period

1.9 years

First QC Date

April 10, 2008

Last Update Submit

March 4, 2013

Conditions

Breast Cancer

Keywords

recurrent breast cancerstage I breast cancerstage II breast cancerstage IIIA breast cancerstage IIIB breast cancerstage IIIC breast cancer

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Evaluation of the impact of MRS data on treatment planning for radiotherapy and/or surgery in women with breast cancer

    After the last scan

Study Arms (2)

Women with breast cancer

EXPERIMENTAL

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

Genetic: proteomic profilingProcedure: lumpectomy or mastectomyProcedure: dynamic contrast-enhanced magnetic resonance imagingProcedure: histopathologic examinationProcedure: magnetic resonance spectroscopy

Healthy volunteers

NO INTERVENTION

Women without breast cancer undergo DCE-MRI and MRS.

Interventions

proteomic profilingGENETIC

at the time of each procedure.

Also known as: proteomic analysis
Women with breast cancer
lumpectomy or mastectomyPROCEDURE

removal of breast tumor or removal of the entire breast in which the tumor is located

Also known as: None noted
Women with breast cancer
dynamic contrast-enhanced magnetic resonance imagingPROCEDURE

Prior to initiation of treatment

Also known as: DCE-MRI
Women with breast cancer
histopathologic examinationPROCEDURE

After the breast tumor has been removed, examination of the tumor under a microscope to determine the type and grade of breast cancer

Also known as: Not noted
Women with breast cancer
magnetic resonance spectroscopyPROCEDURE

Prior to initiation of treatment

Also known as: MRS
Women with breast cancer

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Mastectomy, SegmentalMastectomyMagnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, OperativeSpectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • A. Bapsi Chakravarthy, MD

    Vanderbilt-Ingram Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 10, 2008

First Posted

April 11, 2008

Study Start

November 1, 2003

Primary Completion

October 1, 2005

Study Completion

January 1, 2008

Last Updated

March 5, 2013

Record last verified: 2013-03