The Food and Drug Administration (FDA) has approved Clariscan (gadoterate meglumine; GE Healthcare), a macrocyclic, gadolinium-based contrast agent, for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity.
The approval was based on data from 2 clinical trials (Study A and Study B) that assessed the efficacy and safety of Clariscan in patients with known or suspected CNS lesions. Study A evaluated Clariscan in 364 adult and 38 pediatric patients aged ≥2 years. Adults were randomized to receive either Clariscan or gadopentetate dimeglumine, while all pediatric patients received Clariscan. In Study B, the MR images were reread for 150 adult patients from Study A. Images (pre-contrast, post-contrast and “paired pre- and post-contract”) were interpreted by 3 independent off-site readers blinded to clinical information.
Results from both studies showed Clariscan provided a statistically significant improvement for all 3 primary visualization components of contrast enhancement, border delineation and internal morphology. Moreover, lesion visualization was improved in the Clariscan treatment arm. More lesions were observed on the paired images than the pre-contrast images.
With regard to safety, the most common treatment-emergent adverse events were nausea, headache, injection site pain, injection site coldness, and rash. Clariscan carries a Boxed Warning regarding an increased risk of nephrogenic systemic fibrosis; the risk appears to be highest among patients with chronic, severe kidney disease or acute kidney injury.
Clariscan is a paramagnetic molecule that develops a magnetic moment when placed in a magnetic field. This enhances the relaxation rates of water protons in its vicinity, leading to an increase in signal intensity of tissues. The product is supplied as 0.5mmol/mL strength in 10mL, 15mL, and 20mL single-dose vials.
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