Rose Medical Center
Denver, Colorado, 80220, United States
NCT Number: NCT01433640
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.
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Notify Me25 year and older
Female
Observational
Denver, Colorado, 80220, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Hologic, Inc.
Industry
Evaluation of Contrast-enhanced Mammography and Contrast-enhanced Breast Tomosynthesis: Comparison to Contrast-enhanced Breast MRI- A Pilot Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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