UConn Health
This study will evaluate the efficacy and safety of Gadopiclenol, an FDA-approved contrast agent, for visualizing pituitary lesions on MR images by comparing with the comparator, Gadobutrol, a clinically widely used contrast agent. The study is double-blinded, so neither the participants nor the researchers know which contrast agent is being used during each scan to avoid the bias of results.
Gadopiclenol (brand name Elucirem), initially invented by Guerbet, is an FDA-approved macrocyclic gadolinium-based contrast agent (GBCA) with high relaxivity and high kinetic stability. The higher relaxivity allows for a lower dose of gadopiclenol, reducing the total amount of gadolinium administration (hence reducing the toxicity of gadolinium) while preserving imaging quality. Gadopiclenol was approved by the FDA with a recommended dose of 0.05 mmol/kg for adults and pediatric patients aged 2 years and older. The PICTURE Trial demonstrated that Gadopiclenol at 0.05 mmol/kg which is half dos…
Inclusion criteria: 1. Male adult patient who is at 18 years old or above, or female adult patient who is at 55 years old or above. 2. Patient presenting with known or highly suspected pituitary lesion(s) with focal areas of disrupted Blood Brain Barrier (BBB) (e.g., primary and secondary tumors) based on results of a previous imaging procedure such as Computed Tomography (CT) or MRI, which should have been performed within 12 months prior to informed consent form signature. 3. Patient scheduled for a contrast-enhanced MRI examination with a focus on pituitary for clinical reasons and agreein…
The enhanced images by Gadopiclenol and Gadobutrol will be compared.
Gadobutrol will be used as a comparator
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