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.
Male adult patient who is at 18 years old or above, or female adult patient who is at 55 years old or above.
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.
Patient scheduled for a contrast-enhanced MRI examination with a focus on pituitary for clinical reasons and agreeing to have a second contrast-enhanced MRI examination for the purpose of the trial.
If the patient was treated (either with radiation, surgery, biopsy or other relevant treatments) for a pituitary condition between previous imaging evaluation and trial MRI, there should still be a high suspicion of remaining lesion(s) on the basis of available clinical information.
Patient presenting with known class III/IV congestive heart failure according to the New York Heart Association classification (NYHA).
Patient having received any investigational medicinal product within 7 days prior to trial entry or scheduled to receive any investigational treatment in the course of the trial.
Patient presenting with any contraindication to MRI examinations.
Patient previously randomized in this trial.
Crossover
Gadopiclenol
DrugThe enhanced images by Gadopiclenol and Gadobutrol will be compared.
Gadobutrol (Gadavist, BAY86-4875)
DrugGadobutrol will be used as a comparator
hypointense for lesions with respect to pituitary
The primary outcome measures will include both subjective assessments and an objective measure. The subjective assessments will include part 1) the lesion intensity of the pituitary either having: a) Not Hypointense; b) Mildly Hypointense; c) Markedly Hypointense and part 2) the overall diagnostic quality of the contrast vs noncontrast and of the two contrast agent ( Godopiclinol vs. Godobutrol) side by side as: a) Prefer 1; b) No difference; c) Prefer 2. The objective measure is the Contrast/Noise intensity of the pituitary: \[Signal Intensity Background Pituitary - Signal Intensity Lesion\] / Signal Intensity Air
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