DICES


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

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