Efficacy and Safety of Gadopiclenol with Contrast-enhanced MRI of the Central Nervous System Published

February 6, 2023 — Bracco Imaging, an innovative world leader delivering end-to-end products and solutions through a comprehensive portfolio inclusive of precision diagnostic imaging modalities, announced today the recent publication of the PICTURE study in Investigative Radiology.2 

The PICTURE study was a within-patient, crossover, blinded comparison of the safety and efficacy of 0.05 mmol/kg gadopiclenol (VUEWAY) with 0.1 mmol/kg gadobutrol (Gadavist) in adult patients with suspected CNS disease. Despite being administered at half the dose of Gadavist, VUEWAY provided greater enhancement of contrast between the CNS lesions and the surrounding brain and spine structures, and similar quality of visualization of brain and spine disease.2 The type and severity of adverse events (AEs) were similar with the two gadolinium-based contrast agents (GBCAs), with the AE rate being slightly lower following the administration of VUEWAY (4.9%) as compared with Gadavist (6.9%).  

The positive results of this study, along with supporting findings from the Phase III PROMISE trial in MRI of the body,3  were included in the regulatory application for gadopiclenol submitted to the US FDA, resulting in Priority Review and subsequent approval in 2022. Bracco will commercialize gadopiclenol as VUEWAY (gadopiclenol) injection and VUEWAY (gadopiclenol) Pharmacy Bulk Package in 2023. 

“Following the FDA approval of gadopiclenol in September 2022, we are pleased to share these data, which further support the potential of VUEWAY as a new MRI contrast agent,” said Fulvio Renoldi Bracco, Vice-Chairman & CEO of Bracco Imaging. “By delivering the same diagnostic image quality at half the dose of Gadavist, VUEWAY now allows providers to reduce exposure without compromising the diagnostic quality of a contrast-enhanced MRI of the brain and spine.” 

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 005 mmol/kg gadopiclenol over unenhanced MRI alone for all lesion visualization 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 visualization 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).  

“We are very pleased with the results of the PICTURE study, which shows that 0.05 mmol/kg VUEWAY provides greater contrast enhancement and similar quality of visualization of CNS lesions compared with a twice higher dose of gadobutrol (Gadavist),” said Alberto Spinazzi, MD, Chief Medical and Regulatory Officer at Bracco. “The higher potency of gadopiclenol is due to its markedly higher relaxivity compared with that of Gadavist and of the other GBCAs available in clinical use.”1  

VUEWAY will be manufactured in the U.S. with market availability anticipated in 2023. VUEWAY injection is approved for use in adult and pediatric patients aged 2 years and older with magnetic resonance imaging (MRI) of the CNS and the body (head and neck, thorax, abdomen, pelvis and musculoskeletal system).4  

For more information: https://www.vueway.com/ 

References: 

1Robic C, Port M, Rousseaux O, et al. Physicochemical and Pharmacokinetic Profiles of Gadopiclenol: A New Macrocyclic Gadolinium Chelate with High T1 Relaxivity. Invest Radiol 2019; 54: 475-484.

2 Loevner L, Kolumban B, Hutoczki G, et al. Efficacy and Safety of Gadopiclenol for Contrast-Enhanced MRI of the Central Nervous System. The PICTURE Randomized Clinical Trial. Invest Radiol. 2022 Dec.

3 Clinical Study Report of Study GDX-44-011. Data on file.

4 Vueway (gadopiclenol) injection Full Prescribing Information. Monroe Twp., NJ: Bracco Diagnostics Inc.; September 2022.  

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