Study overview
RecruitingDICES
Diffrent Iodine Contrast media Effectiveness and Safety in Contrast Enhanced Mammography
Study narrative
Clinical and operational context.
Description of the study: The study was planned as a single-site clinical trial with double-blind and unblinded indirect analysis after 300 patients completed participation in the trial. A total of 900 patients were assumed to be recruited, who will be diagnosed with breast cancer using contrast-enhanced spectral mammography and MRI.
Aims of the trial:
- To evaluate the diagnostic efficacy of Ultravist contrast in breast cancer diagnosis by contrast-enhanced mammography based on comparison with contrast-enhanced mammography with Omnipaque contrast and breast MRI in breast cancer screening.
- Quantitative and qualitative evaluation of the strength of enhancement of lesions in images of contrast-enhanced mammography with Ultravist and Omnipaque contrasts.
- Evaluation of the correlation of bedding enhancement in contrast-enhanced mammography versus bedding enhancement in breast MRI.