Dual-energy Contrast-enhanced (2D and 3D Mammography Versus Contrast-enhanced MRI)- A Pilot Study
This is a pilot study to evaluate 2D contrast-enhanced mammography image and 3D (tomosynthesis) contrast-enhanced images to contrast enhanced MRI in women with greater than 95% probability of breast cancer (BIRADS 5) or confirmed breast cancer (BIRADS 6).This study will then be used to design additional studies.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Evaluation of Contrast-enhanced Mammography and Contrast-enhanced Breast Tomosynthesis: Comparison to Contrast-enhanced Breast MRI- A Pilot Study|
- A PILOT study to determine Cancer lesion enhancement with CEM and CEBT is non-inferior to that of CEMRI. [ Time Frame: Fall 2012 ] [ Designated as safety issue: No ]
This Pilot study is designed to evaluate two x-ray contrast methods with contrast enhanced MRI. Each subject will be imaged with CEM, CEBT and CEMRI. The goals for this will be to:
i) Using a Likert scale, Compare the enhancement of breast cancer lesions with CEM, CEBT and CEMRI.
ii) Using a Likert scale, Compare the enhancement of benign breast lesions with CEM, CEBT and CEMRI.
The results of this study will be used to design studies to measure the sensitivity and specificity of CEM and CEBT.
- Comparison of lesion conspicuity [ Time Frame: up to one year post study enrollment ] [ Designated as safety issue: No ]Using a Likert scale the CEM and the CBT images will be compared with standard pre-contrast mammography and tomosynthesis images to determine lesion conspicuity.
|Study Start Date:||July 2011|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
Subjects will undergo 2D imaging with iodine contrast.
Contrast-enhanced Breast Tomosynthesis
Subjects will undergo 3D imaging with iodine contrast.
Each subject imaged with iodine contrast will also be imaged with contrast-enhanced MRI using gadolinium.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01433640
|United States, Colorado|
|Rose Medical Center|
|Denver, Colorado, United States, 80220|
|Principal Investigator:||John Lewins, MD||Rose Breast Center|