Diffrent Iodine Contrast media Effectiveness and Safety in Contrast Enhanced Mammography
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.
Sponsor: Collegium Medicum
EudraCT number: 2023-507644-37
Project Manager/Main Investigator: dr hab. Elżbieta Łuczyńska, prof. UJ
Duration of the study: 2023-2029
Study phase: III