Ultra High Field MRI and MRS Techniques in Diagnosing Breast Cancer
|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: NCT01938651|
Recruitment Status : Terminated (funding ceased)
First Posted : September 10, 2013
Last Update Posted : August 3, 2016
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Procedure: high field strength magnetic resonance imaging Procedure: magnetic resonance spectroscopic imaging Procedure: chemical exchange saturation transfer magnetic resonance imaging Procedure: diffusion-weighted magnetic resonance imaging Procedure: dynamic contrast-enhanced magnetic resonance imaging||Not Applicable|
I. To implement quantitative dynamic contrast-enhanced (DCE)-MRI, diffusion-weighted (DW)-MRI, 31 phosphorus (31P) MRS, magnetization transfer (MT)-MRI, chemical exchange saturation transfer (CEST)-MRI, and high-resolution structural imaging at 7 Tesla in patients for diagnosing breast tumors.
Patients undergo measurement of tumor perfusion and permeability using DCE-MRI, tumor cellularity using DW-MRI, phospholipid metabolism using 31P MRS, macromolecular content using MT-MRI, and cellular protein content using CEST-MRI. Diagnostic performance of one, or a combination, of these metrics will be investigated in the context of breast cancer.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Ultra-High Field (7 Tesla) MRI/MRS Evaluation of Breast Cancer|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||June 2015|
Experimental: Diagnostic (7T ultra high-field MRI/MRS)
Patients undergo measurement of tumor perfusion and permeability using DCE-MRI, tumor cellularity using DW-MRI, phospholipid metabolism using 31P MRS, macromolecular content using MT-MRI, and cellular protein content using CEST-MRI. All of these procedures are integrated into a single MRI exam lasting under 60 min.
Procedure: high field strength magnetic resonance imaging
Undergo 7T MRI
Other Name: high field strength MRI
Procedure: magnetic resonance spectroscopic imaging
Undergo 31P MRS
Procedure: chemical exchange saturation transfer magnetic resonance imaging
Other Name: CEST MRI
Procedure: diffusion-weighted magnetic resonance imaging
Other Name: diffusion-weighted MRI
Procedure: dynamic contrast-enhanced magnetic resonance imaging
Other Name: DCE-MRI
- Sensitivity and specificity [ Time Frame: At time of imaging procedure ]Ninety-percent simultaneous confidence rectangles for sensitivity and specificity will be constructed at the 25th, 50th (median), and 75th percentiles of the model predicted probability of disease.
- Pathological disease status [ Time Frame: At time of imaging procedure ]A generalized linear mixed models analysis of variance with a logit link will be used to predict pathological disease status from MRI and MRS parameters.
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): NCT01938651
|United States, Tennessee|
|Vanderbilt University Medical Center|
|Nashville, Tennessee, United States, 37232|
|Principal Investigator:||Thomas Yankeelov||Vanderbilt-Ingram Cancer Center|