Ultra High Field MRI and MRS Techniques in Diagnosing Breast Cancer
|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 MRIProcedure: magnetic resonance spectroscopic imaging
Undergo 31P MRS
Other Names:Procedure: chemical exchange saturation transfer magnetic resonance imaging
Other Name: CEST MRIProcedure: diffusion-weighted magnetic resonance imaging
Other Name: diffusion-weighted MRIProcedure: 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.
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|