Evaluation of Patients With Breast Cancer Using DCE-MRI, MRS, and Proteomics
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00656604|
Recruitment Status : Completed
First Posted : April 11, 2008
Last Update Posted : March 5, 2013
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.
|Condition or disease||Intervention/treatment|
|Breast Cancer||Genetic: proteomic profiling Procedure: lumpectomy or mastectomy Procedure: dynamic contrast-enhanced magnetic resonance imaging Procedure: histopathologic examination Procedure: magnetic resonance spectroscopy|
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Patients With Breast Cancer Using Dynamic Contrast-Enhanced Magnetic Resonance Imaging, Magnetic Resonance Spectroscopy, and Proteomics|
|Study Start Date :||November 2003|
|Primary Completion Date :||October 2005|
|Study Completion Date :||January 2008|
Experimental: Women with breast cancer
Patients undergo DCE-MRI and MRS prior to their breast cancer surgery.
Genetic: proteomic profiling
at the time of each procedure.
Other Name: proteomic analysisProcedure: lumpectomy or mastectomy
removal of breast tumor or removal of the entire breast in which the tumor is located
Other Name: None notedProcedure: dynamic contrast-enhanced magnetic resonance imaging
Prior to initiation of treatment
Other Name: DCE-MRIProcedure: 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
Other Name: Not notedProcedure: magnetic resonance spectroscopy
Prior to initiation of treatment
Other Name: MRS
No Intervention: Healthy volunteers
Women without breast cancer undergo DCE-MRI and MRS.
- 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 [ Time Frame: 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.
- Evaluation of the impact of MRS data on treatment planning for radiotherapy and/or surgery in women with breast cancer [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00656604
|Study Chair:||A. Bapsi Chakravarthy, MD||Vanderbilt-Ingram Cancer Center|