PROMISE Reinforces Safety, Efficacy of Gadopiclenol MRI Contrast
The PROMISE trial results, published in Radiology, demonstrate that gadopiclenol provides similar lesion visualization and contrast enhancement at a gadolinium dose of 0.05 mmol/kg versus a full dose of gadobutrol (0.1 mmol/kg). Bracco Imaging has launched gadopiclenol as VUEWAY (gadopiclenol) solution for injection and VUEWAY (gadopiclenol) Pharmacy Bulk Package, following the 2022 approval of gadopiclenol by the US FDA.
The PROMISE study was a prospective, multinational, crossover (within-patient), double-blind comparison of the safety and efficacy of 0.05 mmol/kg gadopiclenol (VUEWAY) with 0.1 mmol/kg gadobutrol (Gadavist) in adult patients referred for contrast-enhanced magnetic resonance imaging (MRI) of head and neck, thorax (including breast), abdomen (including liver, pancreas, and kidneys), pelvis (including ovaries, uterus, and prostate), and musculoskeletal (including extremities). Despite being administered at half the dose of gadobutrol, gadopiclenol provided a comparable degree of contrast enhancement and quality of morphologic assessment of lesions. The type and severity of adverse events (AEs) were similar with the two gadolinium-based contrast agents, with VUEWAY (4.2%) having a slightly lower rate to that of Gadavist (5.5%).
The publication of the results of the PROMISE Study comes on the heels of those of the PICTURE clinical trial, which were published in Investigative Radiology and showed non-inferior quality of morphologic assessment of lesions of the brain and spine with 0.05 mmol/kg VUEWAY compared with 0.1 mmol/kg gadobutrol (Gadavist). The combined results of the PROMISE and PICTURE trials, and additional clinical evidence, supported the regulatory application for gadopiclenol submitted to the U.S. FDA, resulting in Priority Review and subsequent approval in 2022. Bracco has launched gadopiclenol in the US market as VUEWAY (gadopiclenol) injection and VUEWAY (gadopiclenol) Pharmacy Bulk Package, with a series of hospitals leading first clinical usage.
"Before gadopiclenol, most of the GBCAs available for clinical use were indicated for the brain, spine, or central nervous system with narrow indications for the body, such as the breast, liver, and heart,i" said Fulvio Renoldi Bracco, Vice-Chairman and CEO of Bracco Imaging. "The publication of this data reinforces VUEWAY injection as a boundary-pushing and novel MRI contrast agent across the central nervous system (the brain, spine, and surrounding tissues) and body (the head and neck, thorax, abdomen, pelvis, and musculoskeletal system).
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 visualization 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.
"The results of the PROMISE Study led to the approval of the use of gadopiclenol with MRI of the head and neck, thorax, abdomen, pelvis, and the musculoskeletal system," said Alberto Spinazzi, MD, Chief Medical and Regulatory Officer at Bracco. "Of note, gadopiclenol was approved for both MRI of the central nervous system and of the body at the dose of 0.05 mmol/kg, which showed to provide similar contrast enhancement efficacy compared with a dose of 0.1 mmol/kg of Gadavist. This is thanks to the high relaxivity of gadopiclenol, the highest among all the available GBCAs.
VUEWAY injection is a Group II agent within the American College of Radiology's classification of gadolinium-based agents relative to the risk of nephrogenic systemic fibrosis (NSF), indicating association with few if any, unconfounded cases. It is approved for use in adult and pediatric patients aged 2 years and older with magnetic resonance imaging (MRI) of the CNS (brain, spine, and surrounding tissues) and the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system).