Gadopiclenol (1) – Elucirem®

• Clinical trials
  • The PICTURE and PROMIS studies were blinded, randomised, controlled crossover trials with similar study designs, in which gadopiclenol was compared with gadobutrol.

Adults, adolescents and children aged 2 years and over for whom contrast-enhanced magnetic resonance imaging is indicated to improve the detection and visualisation of pathologies involving a disruption of the blood-brain barrier and/or vascular abnormalities in specific areas of the body

• For adults, adolescents and children aged 2 years and over for whom contrast-enhanced magnetic resonance imaging is indicated to improve the detection and visualisation of pathologies involving a disruption of the blood-brain barrier and/or vascular anomalies in specific areas of the body, an additional benefit is not proven.
• Overall, therefore, the additional benefit of gadopiclenol compared with the appropriate comparator therapy is not proven.
• Overall assessment
  • Overall, no data were presented that fulfil the necessary criteria for establishing additional benefit. On balance, therefore, additional benefit of gadopiclenol over the appropriate comparator therapy is not proven.

Courtesy translation only, please refer to the German original.