Bracco Imaging has issued a statement on new results published in the journal Radiology which found that gadopiclenol (VUEWAY), which has half the dose (or the amount) of gadolinium found in other available gadolinium-based contrast agents, provides similar lesion visualization and contrast enhancement compared with gadobuterol (Gadavist). Image courtesy: Getty Images
July 25, 2023 — Bracco Imaging has issued a statement on new results published in the journal Radiology which found that gadopiclenol (VUEWAY), which has half the dose (or the amount) of gadolinium found in other available gadolinium-based contrast agents, provides similar lesion visualization and contrast enhancement compared with gadobuterol (Gadavist).
The findings come from the PROMISE (gadoPiclenol foR bOdy MagnetIc reSonancE) study, a multicenter, prospective, randomized, double-blind, controlled, crossover, phase 3 study sponsored by Guerbet and conducted between August 2019 and December 2020 at 33 centers (including 20 university teaching hospitals) in 11 countries (ClinicalTrials.gov identifier NCT03986138), according to a statement detailing the research released by Bracco Imaging.
This 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) focused on adult patients referred for contrast-enhanced MRI of certain body regions. The results also follow those of the PICTURE clinical trial published in Investigative Radiology in May, 2023, which found the non-inferior quality of morphologic assessment of lesions of the brain and spine with VUEWAY compared with Gadavist.
The results of the multicenter, international PROMISE clinical trial 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).[i]
In a July 19 statement announcing the published research, Bracco Imaging added that it has launched gadopiclenol as VUEWAY (gadopiclenol) solution for injection and VUEWAY (gadopiclenol) Pharmacy Bulk Package, following the 2022 approval of gadopiclenol by the United States Food and Drug Administration (U.S. FDA).[ii], further noting that Gadopiclenol is highly stable and shows the highest relaxivity among the gadolinium-based contrast agents available for clinical use.ii,[iii],[iv],[v],[vi],[vii],[viii]
Study Details
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), specified the company in its statement, which included the following additional information:
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%).i
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).[ix]
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 U.S. 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 in the statement. He added, "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).ii"
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.i
The Radiology published study was conducted by Christiane Kuhl, MD, Department of Diagnostic and Interventional Radiology, Aachen University Hospital, Aachen, Germany; Tibor Csőszi, MD, Department of Oncology, Hetenyi Geza Korhaz, Szolnok, Hungary; Wojciech Piskorski, MD, Department of Medical Oncology, Rydgier Memorial Hospital, Krakow, Poland; Tomasz Miszalski, MD, Department of Clinical Radiology and Imaging Diagnostics, 4th Military Hospital, Wroclaw, Poland; Jeong-Min Lee, PhD, MS, Department of Radiology, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea; and Pamela M. Otto, MD, Department of Radiology, University of Texas Health Science Center at San Antonio, San Antonio, TX.
"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,ii" said Alberto Spinazzi, MD, Bracco Chief Medical and Regulatory Officer. "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.” ii,iii,IV,V,VI,VII,VIII
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.[x] 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).ii
More information: www.bracco.com
VUEWAY injection is now available to order from Bracco Diagnostics Inc. Visit VUEWAY.com for more information, including its full Prescribing Information.
VUEWAY (gadopiclenol) solution for injection Indications
VUEWAY injection is indicated in adults and children aged 2 years and older for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in: the central nervous system (brain, spine and surrounding tissues); the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system).
IMPORTANT SAFETY INFORMATION
WARNING: NEPHROGENIC SYSTEMIC FIBROSIS (NSF)
Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of GBCAs in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle and internal organs.
The risk for NSF appears highest among patients with:
Chronic, severe kidney disease (GFR < 30 mL/min/1.73 m2), or
Acute kidney injury.
Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (e.g. age > 60 years, hypertension, diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing. For patients at highest risk for NSF, do not exceed the recommended VUEWAY dose and allow a sufficient period of time for elimination of the drug from the body prior to any re-administration.
Contraindications
VUEWAY injection is contraindicated in patients with history of hypersensitivity reactions to VUEWAY.
Warnings
Risk of nephrogenic systemic fibrosis is increased in patients using GBCA agents that have impaired elimination of the drugs, with the highest risk in patients with chronic, severe kidney disease as well as patients with acute kidney injury. Avoid use of GBCAs among these patients unless the diagnostic information is essential and not available with non-contrast MRI or other modalities.
Hypersensitivity reactions, including serious hypersensitivity reactions, could occur during use or shortly following VUEWAY administration. Assess all patients for any history of a reaction to contrast media, bronchial asthma and/or allergic disorders, administer VUEWAY only in situations where trained personnel and therapies are promptly available for the treatment of hypersensitivity reactions, and observe patients for signs and symptoms of hypersensitivity reactions after administration.
Gadolinium retention can be for months or years in several organs after administration. The highest concentrations (nanomoles per gram of tissue) have been identified in the bone, followed by other organs (brain, skin, kidney, liver and spleen). Minimize repetitive GBCA imaging studies, particularly closely spaced studies, when possible.
Acute kidney injury requiring dialysis has occurred with the use of GBCAs in patients with chronically reduced renal function. The risk of acute kidney injury may increase with increasing dose of the contrast agent.
Ensure catheter and venous patency before injecting as extravasation may occur, and cause tissue irritation.
VUEWAY may impair the visualization of lesions seen on non-contrast MRI. Therefore, caution should be exercised when VUEWAY MRI scans are interpreted without a companion non-contrast MRI scan.
The most common adverse reactions (incidence ≥ 0.5%) are injection site pain (0.7%), and headache (0.7%).
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please click here for full Prescribing Information for VUEWAY, including BOXED WARNING on Nephrogenic Systemic Fibrosis.
Manufactured for Bracco Diagnostics Inc. by Liebel-Flarsheim Company LLC - Raleigh, NC, USA 27616.
VUEWAY is a registered trademark of Bracco Imaging S.p.A.
All other trademarks and registered trademarks are the property of their respective owners.
References:
[i] Kuhl C, Csőszi T, Piskorski W et al. Efficacy and Safety of Half-Dose Gadopiclenol versus Full-Dose Gadobutrol for Contrast-enhanced Body MRI Radiology: Volume 308: Number 1—July 2023
[ii] Vueway (gadopiclenol) solution for injection, 485.1 mg/mL/ Full Prescribing Information and Patient Medication Guide. Monroe Twp., NJ: Bracco Diagnostics Inc.; September 2022.
[iii] Robic 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.
[iv] GADAVIST (gadobutrol) Injection. Full Prescribing Information and Patient Medication Guide. Bayer HealthCare Pharmaceuticals Inc. Whippany, NJ; April 2022.
[v] DOTAREM (gadoterate meglumine) Injection. Full Prescribing Information. Guerbet LLC. Princeton, NJ. April 2022.
[vi] CLARISCAN (gadoterate meglumine) injection for intravenous use. Full Prescribing Information and Patient Medication Guide. GE Healthcare. Chicago, IL; February 2020.
[vii] ProHance (Gadoteridol) Injection, 279.3 mg/mL. Full Prescribing Information and Patient Medication Guide. Monroe Twp., NJ: Bracco Diagnostics Inc.; June 2022.
[viii] MultiHance (gadobenate dimeglumine) injection, 529 mg/mL. Full Prescribing Information and Patient Medication Guide. Monroe Twp., NJ: Bracco Diagnostics Inc.; August 2018.
[ix] 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.
[x] American College of Radiology. ACR Manual on Contrast Media. 2023.
SOURCE Bracco
[v] DOTAREM (gadoterate meglumine) Injection. Full Prescribing Information. Guerbet LLC. Princeton, NJ. April 2022.
[vi] CLARISCAN (gadoterate meglumine) injection for intravenous use. Full Prescribing Information and Patient Medication Guide. GE Healthcare. Chicago, IL; February 2020.
[vii] ProHance (Gadoteridol) Injection, 279.3 mg/mL. Full Prescribing Information and Patient Medication Guide. Monroe Twp., NJ: Bracco Diagnostics Inc.; June 2022.
[viii] MultiHance (gadobenate dimeglumine) injection, 529 mg/mL. Full Prescribing Information and Patient Medication Guide. Monroe Twp., NJ: Bracco Diagnostics Inc.; August 2018.
[ix] 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.
[x] American College of Radiology. ACR Manual on Contrast Media. 2023.
April 24, 2024 
