A Multicenter, Randomized, Prospective Double-blind, Cross-over Phase 3 Study to Evaluate the Efficacy and Safety of 0.04 mmol Gd/kg Body Weight of Gadoquatrane for MRI in Adults With Known or Suspected Pathology of the Central Nervous System (CNS), Compared to 0.1 mmol Gd/kg Approved Macrocyclic Gadolinium-based Contrast Agents (GBCAs)

Researchers are looking for a better way to help people with known or suspected brain or spinal cord-related problems scheduled for a "contrast-enhanced" Magnetic Resonance Imaging (MRI).
MRI is used by doctors to create detailed images of the inside of the body to identify health problems. Sometimes doctors need to inject a contrast agent into a patient's vein to perform a so called "contrast-enhanced" MRI (CE-MRI). Such CE-MRI examinations may support doctors to identify certain health problems or improve the evaluation.
The contrast agents commonly used in MRI are gadolinium-based contrast agents (GBCAs). GBCAs contain a "rare earth" element called gadolinium (Gd). Gadoquatrane is a new contrast agent under development with a lower amount of Gd needed per CE-MRI.
The main purpose of this study is to learn whether CE-MRI scans with gadoquatrane work better than MRI scans without the use of a contrast agent (GBCA). The researchers will compare the ability to detect brain and spinal cord-related problems in gadoquatrane-MRI scans to plain-MRI scans without the use of a contrast agent.
The participants will undergo 2 MRI scans, one with gadoquatrane and one with currently used GBCA. Both contrast agents will be injected into the vein.
Each participant will be in the study for between 6 and 42 days with up to 7 doctor visits.
At the start or during the study, the doctors and their study team will:
take blood and urine samples
do physical examinations
check blood pressure and heart rate
review the MRI scans obtained in the study and decide on the diagnosis
ask the participants questions about how they are feeling and what adverse events they are having.
An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatments.

Start Date24 Jul 2023

Sponsor / Collaborator

Bayer AG

NCT05915728 / CompletedPhase 3

A Multicenter, Randomized, Prospective Double-blind, Cross-over Phase 3 Study to Evaluate the Efficacy and Safety of 0.04 mmol Gd/kg Body Weight of Gadoquatrane for MRI in Adults With Known or Suspected Pathology of Any Body Region (Except CNS), Compared to 0.1 mmol Gd/kg Approved Macrocyclic Gadolinium-based Contrast Agents (GBCAs)

Researchers are looking for a better way to help people with any known or suspected problems (except brain or spinal cord-related problems) scheduled for a "contrast-enhanced" Magnetic Resonance Imaging (MRI).
MRI is used by doctors to create detailed images of the inside of the body to identify health problems. Sometimes doctors need to inject contrast agent into a patient's vein to perform a so called "contrast-enhanced" MRI (CE-MRI). Such CE-MRI examinations may support doctors to identify certain health problems or improve the evaluation.
The contrast agents commonly used in MRI are gadolinium-based contrast agents (GBCAs). GBCAs contain a "rare earth" element called gadolinium (Gd). Gadoquatrane is a new contrast agent under development with a lower amount of Gd needed per CE-MRI.
The main purpose of this study is to learn whether CE-MRI scans with gadoquatrane work better than MRI scans without the use of a contrast agent (GBCA). The researchers will compare the ability to detect known or suspected problems (except brain or spinal cord-related problems) with gadoquatrane-MRI scans to plain-MRI scans without the use of a contrast agent.
The participants will undergo 2 MRI scans, one with gadoquatrane and one with currently used GBCA. Both contrast agents will be injected into the vein.
Each participant will be in the study for between 6 and 42 days with up to 7 doctor visits.
At the start or during the study, the doctors and their study team will:
take blood and urine samples
do physical examinations
check blood pressure and heart rate
review the MRI scans obtained in the study and decide on the diagnosis
ask the participants questions about how they are feeling and what adverse events they are having.
An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatments.

Start Date24 Jul 2023

Sponsor / Collaborator

Bayer AG

NCT05357833 / CompletedEarly Phase 1IIT

Novel Imaging Markers of Innate Immune Activation in Secondary Progressive Multiple Sclerosis

This pilot study takes the innovative approach of using ultrasmall superparamagnetic iron oxide (USPIO) nanoparticle enhanced MRI to measure activity of the innate immune system within MS lesions. Activity of innate immunity has been hypothesized as one of the critical pathologic processes underpinning neurologic worsening in progressive MS. As such, in the short term this project proposes to investigate USPIO uptake in SPMS lesions as a promising in vivo imaging biomarker for chronic-active lesions, as distinguished from chronic-inactive lesions.

Start Date01 Jun 2022

Sponsor / Collaborator

University of Utah

100 Clinical Results associated with Gadoteridol

100 Translational Medicine associated with Gadoteridol

100 Patents (Medical) associated with Gadoteridol

444

Literatures (Medical) associated with Gadoteridol

01 Aug 2024·Journal of magnetic resonance imaging : JMRI

Efficacy of Whole‐Blood Model of Gadolinium‐Based Contrast Agent Relaxivity in Predicting Vascular MR Signal Intensity In Vivo

Article

Author: Kirchin, Miles A. ; Maki, Jeffrey H. ; Norris, Evan C. ; Wilson, Gregory J. ; Schneider, Guenther ; Clark, Toshimasa J.

Background:

Previous in vitro studies have described sub‐linear longitudinal and heightened transverse H2O relaxivities of gadolinium‐based contrast agents (GBCAs) in blood due to their extracellular nature. However, in vivo validation is lacking.

Purpose:

Validate theory describing blood behavior of R1 and R2* in an animal model.

Study Type:

Prospective, animal.

Animal Model:

Seven swine (54–65 kg).

Field Strength/Sequence:

1.5 T; time‐resolved 3D spoiled gradient‐recalled echo (SPGR) and quantitative Look‐Locker and multi‐echo fast field echo sequences.

Assessment:

Seven swine were each injected three times with 0.1 mmol/kg intravenous doses of one of three GBCAs: gadoteridol, gadobutrol, and gadobenate dimeglumine. Injections were randomized for rate (1, 2, and 3 mL/s) and order, during which time‐resolved aortic 3D SPGR imaging was performed concurrently with aortic blood sampling via an indwelling catheter. Time‐varying [GBCA] was measured by mass spectrometry of sampled blood. Predicted signal intensity (SI) was determined from a model incorporating sub‐linear R1 and R2* effects (whole‐blood model) and simpler models incorporating linear R1, with and without R2* effects. Predicted SIs were compared to measured aortic SI.

Statistical Tests:

Linear correlation (coefficient of determination, R2) and mean errors were compared across the SI prediction models.

Results:

There was an excellent correlation between predicted and measured SI across all injections and swine when accounting for the non‐linear dependence of R1 and high blood R2* (regression slopes 0.91–1.04, R2 ≥ 0.91). Simplified models (linear R1 with and without R2* effects) showed poorer correlation (slopes 0.67–0.85 and 0.54–0.64 respectively, both R2 ≥ 0.89) and higher averaged mean absolute and mean square errors (128.4 and 177.4 vs. 42.0, respectively, and 5506 and 11,419 vs. 699, respectively).

Data Conclusion:

Incorporating sub‐linear R1 and high first‐pass R2* effects in arterial blood models allows accurate SPGR SI prediction in an in vivo animal model, and might be utilized when modeling MR blood SI.

Level of Evidence:

Technical Efficacy:

Stage 1

01 Jul 2024·EUROPEAN JOURNAL OF RADIOLOGY

Assessment of first-time and repeated acute adverse reactions to gadolinium-based contrast agents in MRI: A retrospective study

Article

Author: Suto, Takayuki ; Ujita, Koichi ; Hirasawa, Hiromi ; Tsushima, Yoshito ; Fukushima, Yasuhiro ; Taketomi-Takahashi, Ayako ; Ozaki, Daisuke

PURPOSE:

To identify gadolinium-based contrast agents (GBCAs)-related and patient-related risk factors for acute adverse reactions (AARs), and to examine the incidence and severity of repeated AARs.

METHODS:

This study retrospectively evaluated all intravenous GBCA injections in MRI studies at a single institution from January 2012 to September 2019. First-time AARs in patients without a past history of AARs and risk factors were assessed using multivariable regression models with generalized estimating equations. For patients with a past history of AAR(s), we evaluated the incidence of repeated AARs using the Fisher's exact test, as well as the severity of these repeated AARs.

RESULTS:

First-time AARs occurred in 129 of 41,827 GBCA injections (0.31 %; 0.70 % of 18,431 patients). With gadoterate meglumine as the reference, the odds ratio (OR) for allergic-like reactions to three GBCAs ranged from 3.27 to 8.03 (p = 0.012 to <0.001). For chemotoxic reactions, the OR was 3.75 (p = 0.001) for gadoteridol. Outpatients had a lower OR for chemotoxic reactions, while higher ORs were observed in head/neck and breast MRI (p < 0.05). The OR for age was 0.99 (p < 0.05). Patients with a past history of AAR(s) had a 3.6 % incidence of mild repeated AARs for all GBCA, significantly higher than the 0.31 % in first-time AARs (p < 0.001). No effectiveness was found for steroid premedication.

CONCLUSION:

The occurrence of first-time AARs was related to the GBCA used and other factors. The incidence of repeated AARs was higher than first-time AARs, though all were mild in severity.

01 Jul 2024·JOURNAL OF NEUROSURGERY

Preclinical evaluation of transaxial intraputaminal trajectory for enhanced distribution of grafted cells in Parkinson’s disease

Article

Author: Colwell, Julia C. ; Emborg, Marina E. ; Coonen, Jennifer ; Bondarenko, Viktoriya ; Pape, Bruce ; Fuchs, Kerri ; Fitz, Casey ; Hurley, Sam ; Metzger, Jeanette M. ; Larson, Paul ; Olsen, Miles ; Bratt-Leal, Andres M. ; Tran, Ha ; Wirth, Edward ; Schultz-Darken, Nancy ; Simmons, Heather A. ; Mancinelli, Anthony ; Brunner, Kevin ; Menna, Viktorie ; Zinnen, Alexandra D.

OBJECTIVE:

The objective of this study was to develop and evaluate the feasibility and safety of a novel transaxial surgical approach for the delivery of human induced pluripotent stem cell–derived dopaminergic neuroprogenitor cells (DANPCs) into the putamen nucleus using nonhuman primates and surgical techniques and tools relevant to human clinical translation.

METHODS:

Nine immunosuppressed, unlesioned adult cynomolgus macaques (4 females, 5 males) received intraputaminal injections of vehicle or DANPCs (0.9 × 105 to 1.1 × 105 cells/µL) under real-time intraoperative MRI guidance. The infusates were combined with 1-mM gadoteridol (for intraoperative MRI visualization) and delivered via two tracks per hemisphere (ventral and dorsal) using a transaxial approach. The total volumes of infusion were 25 µL and 50 µL for the right and left putamen, respectively (infusion rate 2.5 µL/min). Animals were evaluated with a battery of clinical and behavioral outcome measures and euthanized 7 or 30 days postsurgery; full necropsies were performed by a board-certified veterinary pathologist. Brain tissues were collected and processed for immunohistochemistry, including against the human-specific marker STEM121.

RESULTS:

The optimized surgical technique and tools produced successful targeting of the putamen via the transaxial approach. Intraoperative MR images confirmed on-target intraputaminal injections in all animals. All animals survived to scheduled termination without clinical evidence of neurological deficits. The first 4 animals to undergo surgery had mild brain swelling noted at the end of surgery, of which 3 had transient reduced vision; administration of mannitol therapy and reduced intravenous fluid during the surgical procedure addressed these complications. Immunostaining against STEM121 confirmed the presence of grafted cells along the injection track within the targeted putamen area of DANPC-treated animals. All adverse histological findings were limited in scope and consistent with surgical manipulation, injection procedure, and postsurgical inflammatory response to the mechanical disruption caused by the cannula insertion.

CONCLUSIONS:

The delivery system, injection procedure, and DANPCs were well tolerated in all animals. Prevention of mild brain swelling by mannitol dosing and reduction of intravenous fluids during surgery allowed visual effects to be avoided. The results of the study established that this novel transaxial approach can be used to correctly and safely target cell injections to the postcommissural putamen and support clinical investigation.

News (Medical) associated with Gadoteridol

16 Oct 2023

·www.prnewswire.com

Bracco Diagnostics Showcases Innovation and Collaborative Vision at RSNA 2023 Annual Meeting

--Leaders in Radiology Will Share Insights on VUEWAY® (gadopiclenol) solution for injection After the First Year of Use in the U.S.-- --Applied Radiology to Announce Expansion of the Bracco-Supported "Leaders on the Horizon" Program-- MONROE TOWNSHIP, N.J., Oct. 16, 2023 /PRNewswire/ -- Bracco Diagnostics Inc., the U.S. subsidiary of Bracco Imaging S.p.A., a pioneer in diagnostic imaging, is showcasing its commitment to innovation and purpose-driven partnership at the Radiological Society of North America (RSNA) 2023 Annual Meeting, to be held November 26-30 in Chicago, Illinois. This year, Bracco's activities at RSNA are captured by the theme, "Unlocking the Invisible." Through this overarching vision, Bracco is demonstrating its dedication to maximizing diagnostic accuracy and resource efficiency with the aim of improving people's lives. Engagement Opportunities Hosted by Bracco at RSNA 2023: MR Symposium: Bracco presents "The Future is Now: The Novel GBCA Gadopiclenol." This symposium will feature insights from leaders in radiology on how they have implemented VUEWAY injection into their practice since its FDA approval last year, using half the gadolinium (0.05 mmol/kg) compared to other macrocyclic GBCAs with approved doses of 0.1 mmol/kg in approved indications in the U.S.i-v The event will take place on Monday, November 27 at McCormick Place S101AB, South Building, from 9:00 AM – 10:00 AM CST. Please see Indications and Important Safety Information below, including Boxed Warning. "I am delighted to participate in this Bracco-sponsored symposium, as it will be a great opportunity for anyone interested in learning more about gadopiclenol and our initial experience with it for abdominal MR imaging at the University of Wisconsin to date," said Perry J. Pickhardt, MD, Professor of Radiology and Chief of Gastrointestinal Imaging at the University of Wisconsin School of Medicine and Public Health. Max Wintermark, MD, Professor and Chair of Neuroradiology at The University of Texas MD Anderson Cancer Center, said, "I am excited to participate in the Round Table Symposium sponsored by Bracco Diagnostics Inc. This will be a great opportunity for anyone interested in learning more about gadopiclenol and what our experience has been at MD Anderson Cancer Center to date." Supporting the Future of Diagnostic Imaging: The Applied Radiology "Leaders on the Horizon" Residency Program, which is supported by Bracco through an unrestricted educational grant, is expanding globally and will now include all diagnostic imaging modalities. Through this program, scholarships are bestowed upon six radiology resident applicants whose submitted research papers (three clinical research papers and three clinical review articles) are selected for publication by Applied Radiology. These individuals will be honored at a special evening reception hosted by Applied Radiology during RSNA 2023. Additionally, Bracco is thrilled to be entering the fourth year of its 10-year commitment to donate $450,000 to the RSNA Research & Education (R&E) Foundation. Visit Bracco's Booth (#3300): Bracco's booth experience will highlight an array of product offerings and partnerships, including: Comprehensive Diagnostic Contrast Imaging and Delivery Solutions: Bracco remains the sole provider of such a comprehensive breadth of barium sulfate contrast agents following FDA mandates. The company's ongoing commitment to providing a full selection of contrast agents demonstrates its dedication to improving patient diagnostics. Subtle Medical Collaboration: Bracco and Subtle Medical have joined forces in a global collaboration, aiming to explore the integration of artificial intelligence-powered image acquisition, particularly in the context of MR imaging. "At this year's RSNA meeting, we are pleased to demonstrate our dedication to advancing the field of medical imaging through rigorous research and thoughtful, strategic partnership," said Cosimo DePinto, Senior Vice President of Sales and Marketing at Bracco Diagnostics Inc. "Our goal, as it has always been, is to maximize diagnostic efficiency and effectiveness across the full spectrum of imaging procedures, enabling healthcare providers to provide the highest level of care to their patients." Connect with Bracco on LinkedIn and follow #BraccoImaging for more RSNA news. 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 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. About Bracco Imaging Bracco Imaging S.p.A. ("Bracco Imaging"), part of the Bracco Group, is an innovative world leader delivering end-to-end products and solutions through its comprehensive portfolio across diagnostic imaging modalities. Headquartered in Milan, Italy, Bracco Imaging's purpose is to improve people's lives by shaping the future of prevention and precision diagnostic imaging. The Bracco Imaging portfolio includes products and solutions for all key diagnostic imaging modalities: X-ray imaging, magnetic resonance imaging (MRI), Contrast Enhanced Ultrasound (CEUS), and Nuclear Medicine through radioactive tracers and novel PET imaging agents. Bracco Imaging has approximately 3,600 employees and operates in more than 100 markets globally. Bracco Imaging has a well-skilled and innovative Research and Development (R&D) organization with an efficient process-oriented approach and track record in the diagnostic imaging industry. R&D activities are located in four centers based in Italy, Switzerland, the United Kingdom and the United States. Bracco Group global revenues were 1.4 billion Euros in 2020. To learn more about Bracco Imaging, visit . i. VUEWAY® (gadopiclenol) solution for injection, 485.1 mg/mL full Prescribing Information and Patient Medication Guide. Monroe Twp., NJ: Bracco Diagnostics Inc.; September 2022. ii. DOTAREM® (gadoterate meglumine) Injection full Prescribing Information. Princeton, NJ: Guerbet LLC; October 2019. iii. GADAVIST® (gadobutrol) Injection full Prescribing Information and Patient Medication Guide. Whippany, NJ: Bayer HealthCare Pharmaceuticals Inc; April 2022. iv. ProHance® (Gadoteridol) Injection, 279.3 mg/mL full Prescribing Information and Patient Medication Guide. Monroe Twp., NJ: Bracco Diagnostics Inc.; June 2022. v. CLARISCAN™ (gadoterate meglumine) injection for intravenous use full Prescribing Information. Chicago IL: GE Healthcare; November 2020. SOURCE Bracco Imaging

19 Jul 2023

·www.prnewswire.com

Data Reinforcing Efficacy and Safety of Gadopiclenol in Contrast-Enhanced MRI of Certain Body Regions Published in Radiology

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] Bracco 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] 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] MONROE TOWNSHIP, N.J., July 19, 2023 /PRNewswire/ -- 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 publication of the PROMISE trial in Radiology.i 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%).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. "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 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, 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.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 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 m 2 ), 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 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. About Bracco Imaging Bracco Imaging S.p.A. ("Bracco Imaging"), part of the Bracco Group, is an innovative world leader delivering end-to-end products and solutions through its comprehensive portfolio across diagnostic imaging modalities. Headquartered in Milan, Italy, Bracco Imaging's purpose is to improve people's lives by shaping the future of prevention and precision diagnostic imaging. The Bracco Imaging portfolio includes products and solutions for all key diagnostic imaging modalities: X-ray imaging, magnetic resonance imaging (MRI), Contrast Enhanced Ultrasound (CEUS), and Nuclear Medicine through radioactive tracers and novel PET imaging agents. Bracco Imaging has approximately 3,600 employees and operates in more than 100 markets globally. Bracco Imaging has a well-skilled and innovative Research and Development (R&D) organization with an efficient process-oriented approach and track record in the diagnostic imaging industry. R&D activities are located in four centers based in Italy, Switzerland, the United Kingdom and the United States. Bracco Group global revenues were 1.4 billion Euros in 2020. To learn more about Bracco Imaging, visit . Bracco Diagnostics Inc. Media Relations (USA) Kimberly Gerweck Senior Manager, Marketing Communications [email protected] D: +1 609-524-2777 [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

Drug ApprovalClinical Result

14 Feb 2023

·www.prnewswire.com

Preeminent Hospitals and Medical Practices Nationwide Lead in Patient Care with First Use of Bracco's VUEWAY™ (gadopiclenol) solution for injection for MRI

Requiring half the gadolinium dosage compared to other macrocyclic gadolinium-based contrast agents (GBCAs) in approved indications in the U.S., gadopiclenol also has the highest relaxivity compared to approved GBCAs1-7 MONROE TOWNSHIP, N.J., Feb. 14, 2023 /PRNewswire/ -- 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 that Wellstar Health System is among the first establishments in the nation to trial VUEWAY™ (gadopiclenol) injection, a recently FDA-approved macrocyclic gadolinium-based contrast agent (GBCA) for use in magnetic resonance imaging (MRI). Gadopiclenol needs only half the dose compared to other GBCAs in approved indications in the U.S. to accomplish the same image clarity due to the fact that it has the highest relaxivity of all GBCAs compared to approved GBCAs.1-7 "We are honored to stand alongside these prestigious leaders of the medical community for the first VUEWAY injections, after FDA approval," said Fulvio Renoldi Bracco, Vice-Chairman & CEO of Bracco Imaging. "We're particularly excited about our innovations in contrast imaging because of the wide-reaching impact across disease categories with 30 million MRI scans conducted annually, globally.8 That these institutions have prioritized offering VUEWAY injection, a novel next-generation MRI contrast agent, reinforces the potential value VUEWAY injection will provide in patient care and diagnostics." VUEWAY (gadopiclenol) injection received FDA approval on Sept. 21, 2022, for use with MRI in adults and pediatric patients aged two years and older to detect and visualize lesions in the central nervous system (brain, spine, and associated tissues) and the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system).7 Two recent Phase III trials sharing similar methodologies and endpoints demonstrate the efficacy and safety of gadopiclenol in MRI of the CNS (the PICTURE trial) and of the body (the PROMISE trial). Combining study populations, over 500 individuals had MRI scans compared when done with gadopiclenol at half the dose of a conventional agent, gadobutrol, at full dose. Even with the lower dosage, blinded readers rated gadopiclenol scans as having comparable image quality.9-11 VUEWAY injection is manufactured in the U.S. by Liebel-Flarsheim Company LLC in Raleigh, NC. VUEWAY injection 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).7 VUEWAY injection is now available to order from Bracco Diagnostics, Inc. Visit VUEWAY.com for more information, including 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 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 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 trademark of Bracco Imaging S.p.A. All other trademarks and registered trademarks are the property of their respective owners. About Bracco Imaging Bracco Imaging S.p.A. ("Bracco Imaging"), part of the Bracco Group, is an innovative world leader delivering end-to-end products and solutions through its comprehensive portfolio across diagnostic imaging modalities. Headquartered in Milan, Italy, Bracco Imaging's purpose is to improve people's lives by shaping the future of prevention and precision diagnostic imaging. The Bracco Imaging portfolio includes products and solutions for all key diagnostic imaging modalities: X-ray imaging, magnetic resonance imaging (MRI), Contrast Enhanced Ultrasound (CEUS), and Nuclear Medicine through radioactive tracers and novel PET imaging agents. Bracco Imaging has approximately 3,600 employees and operates in more than 100 markets globally. Bracco Imaging has a well-skilled and innovative Research and Development (R&D) organization with an efficient process-oriented approach and track record in the diagnostic imaging industry. R&D activities are located in four centers based in Italy, Switzerland, the United Kingdom and the United States. Bracco Group global revenues were 1.4 billion Euros in 2020. To learn more about Bracco Imaging, visit . Bracco Diagnostics Inc. Media Relations (USA) Kimberly Gerweck Senior Manager, Marketing Communications [email protected] D: +1 609-524-2777 1 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. 2 GADAVIST® (gadobutrol) Injection. Full Prescribing Information. Bayer HealthCare Pharmaceuticals Inc. Whippany, NJ; April 2022. 3 DOTAREM® (gadoterate meglumine) Injection. Full Prescribing Information. Guerbet LLC. Princeton, NJ. April 2022. 4 CLARISCAN™ (gadoterate meglumine) injection for intravenous use. Full Prescribing Information. GE Healthcare. Chicago, IL; February 2020. 5 ProHance® (Gadoteridol) Injection. Full Prescribing Information and Patient Medication Guide. Monroe Twp., NJ: Bracco Diagnostics Inc.; June 2022. 6 MultiHance® (gadobenate dimeglumine) Injection. Full Prescribing Information and Patient Medication Guide. Monroe Twp., NJ: Bracco Diagnostics Inc.; August 2018. 7 Vueway™ (gadopiclenol) Injection Full Prescribing Information. Monroe Twp., NJ: Bracco Diagnostics Inc.; September 2022. 8 Lohrke J, et al. 25 Years of Contrast-Enhanced MRI: Developments, Current Challenges and Future Perspectives. Adv Ther. 2016 Jan;33(1):1-28. 9 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. 10 Clinical Study Report of Study GDX-44-010. Data on file. 11 Clinical Study Report of Study GDX-44-011. Data on file. US-VW-2300006 02/23 SOURCE Bracco Diagnostics Inc.

Phase 3Drug Approval

100 Deals associated with Gadoteridol

External Link

KEGG	Wiki	ATC	Drug Bank
D01137	Gadoteridol	V08CA04	DB00597

R&D Status

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Contrast agents	JP	Eisai Co., Ltd.	14 Mar 1996
Contrast agents	JP	Bracco Imaging Italia Srl	14 Mar 1996
Visible Lesion	US	Bracco Diagnostics, Inc.	16 Nov 1992

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