About gadolinium-based contrast agents
Gadolinium-based contrast agents (GBCAs) are used in magnetic resonance imaging (MRI) procedures to help enhance the visibility of certain tissues. Gadolinium is a rare earth metal that has unique magnetic properties that make it useful for MRI imaging.
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About gadopiclenol
Gadopiclenol, initially invented by Guerbet with subsequent contribution of Bracco IP, is a new macrocyclic gadolinium-based contrast agent (GBCA) with high relaxivity. The efficacy and safety of gadopiclenol have been evaluated in MRI of the Central Nervous System, head and neck, thorax, abdomen, pelvis, and musculoskeletal system (For US reference, refer to the approved USPI).
Details on Phase III clinical trials are available on www.ClinicalTrials.gov:
Efficacy and Safety of Gadopiclenol for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI) Full Text View - ClinicalTrials.gov
Efficacy and Safety of Gadopiclenol for Body Magnetic Resonance Imaging (MRI) Full Text View - ClinicalTrials.gov
About the PICTURE trial
The PICTURE trial included 256 patients with known or highly suspected CNS lesion(s). All primary and secondary endpoints of the study were achieved. All blinded readers' evaluations indicated the superiority of the combined unenhanced/contrast-enhanced MRI with 0.05 mmol/kg gadopiclenol over unenhanced MRI alone for all lesion visualisation criteria (p<0.0001). For all three blinded readers, non-inferiority of 0.05 mmol/kg gadopiclenol to 0.1 mmol/kg gadobutrol (Gadavist) was demonstrated for all lesion visualisation criteria (p<0.0001). Results also indicated superior percent of contrast enhancement for all readers (p<0.0001), superior contrast-to-noise ratio for two out of three readers (p<0.01), and superior lesion-to-background contrast ratio with gadopiclenol for all readers (p<0.0001). In correlation with the greater contrast enhancement, the diagnostic quality of the images obtained with 0.05 mmol/kg gadopiclenol were in majority preferred over that provided by 0.1 mmol/kg gadobutrol by all three blinded readers (p<0.001).
About the PROMISE trial2
The PROMISE trial included 273 adult patients suspected of having an enhancing abnormality in one of three different body regions (head/neck, breast/thorax/abdomen/pelvis, or musculoskeletal). Off-site blinded readers with expertise in the respective body regions rated border delineation, internal morphology, and visual contrast enhancement. All primary and secondary endpoints of the study were achieved. For all blinded readers, 0.05 mmol/kg gadopiclenol was non-inferior to 0.1 mmol/kg gadobutrol for all visualisation parameters and all readers (P<.001), and superior to unenhanced images (P<.001). Two of three readers yielded higher percentage enhancement for gadopiclenol (P<.001). Lesion-to-background ratio did not differ. For most participants (75%–83%), readers reported no preference between 0.05 mmol/kg gadopiclenol and 0.1 mmol/kg gadobutrol images.
