Dual-energy Contrast-enhanced (2D and 3D Mammography Versus Contrast-enhanced MRI)- A Pilot Study
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|ClinicalTrials.gov Identifier: NCT01433640|
Recruitment Status : Completed
First Posted : September 14, 2011
Last Update Posted : March 18, 2015
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||30 participants|
|Official Title:||Evaluation of Contrast-enhanced Mammography and Contrast-enhanced Breast Tomosynthesis: Comparison to Contrast-enhanced Breast MRI- A Pilot Study|
|Study Start Date :||July 2011|
|Actual Primary Completion Date :||November 2013|
|Actual Study Completion Date :||February 2014|
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.
- A PILOT study to determine Cancer lesion enhancement with CEM and CEBT is non-inferior to that of CEMRI. [ Time Frame: Fall 2012 ]
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 ]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.
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): NCT01433640
|United States, Colorado|
|Rose Medical Center|
|Denver, Colorado, United States, 80220|
|Principal Investigator:||John Lewins, MD||Rose Breast Center|