Safety Evaluation of Linear and Macrocyclic Gadolinium-Based Contrast Agents for Patients With Mild to Moderate Renal Insufficiency Undergoing Enhanced Magnetic Resonance Imaging (Interventional Prospective Study) Clinical Trial Protocol

The purpose of this study is to evaluate the safety of linear and macrocyclic gadolinium-based contrast agents for patients with mild to moderate renal insufficiency. The study will compare the incidence of adverse events of gadodiamide and gadoteric Acid Meglumine Salt for patients with mild to moderate renal insufficiency undergoing enhanced magnetic resonance imaging.

Start Date01 Mar 2021

Sponsor / Collaborator

Jiangsu Hengrui Pharmaceuticals Co., Ltd.

NCT02371798 / WithdrawnNot ApplicableIIT

Diagnosing Endolymphatic Hydrops in Patients With Meniere Disease Using Magnetic Resonance Imaging With Intravenous Gadolinium Administration

The purpose of this research study is to see if magnetic resonance imaging (MRI) with a double dose of contrast, or dye, and delayed imaging with MRI can help to diagnose Meniere Disease.

Start Date01 Feb 2015

Sponsor / Collaborator

Emory University

NCT02278510 / CompletedEarly Phase 1IIT

A Pilot Trial of Intraparenchymally-Administered Topotecan Using Convection-Enhanced Delivery (CED) in Patients With Suspected Recurrent/Progressive WHO Grade III or IV (High Grade) Glioma Requiring Stereotactic Biopsy

Topotecan is a FDA-approved drug when given by intravenous injection, but it is not effective against brain tumors when given intravenously. The Cleveland Multiport Catheter is a new, investigational device that will be used to deliver topotecan directly into participants' brain tumors. One purpose of this study is to determine whether the Cleveland Multiport Catheter can be used effectively and safely to deliver topotecan directly into brain tumors. This study will also evaluate different doses of topotecan that can be delivered to a participant's brain tumor with use of the Cleveland Multiport Catheter, and it will also examine how their tumor responds to treatment with topotecan.

Start Date09 Dec 2014

Sponsor / Collaborator

The Case Comprehensive Cancer Center

[+1]

100 Clinical Results associated with Gadopentetate Dimeglumine

100 Translational Medicine associated with Gadopentetate Dimeglumine

100 Patents (Medical) associated with Gadopentetate Dimeglumine

5,922

Literatures (Medical) associated with Gadopentetate Dimeglumine

01 Jan 2025·Magnetic Resonance in Medicine

3D MR fingerprinting for dynamic contrast‐enhanced imaging of whole mouse brain

Article

Author: Flask, Chris A. ; Ma, Dan ; Griswold, Mark A. ; Zhu, Junqing ; Zhao, Walter ; Lu, Jiahao ; Yu, Xin ; Wang, Guanhua ; Zhu, Yuran ; Gu, Yuning ; MacAskill, Christina J. ; Dupuis, Andrew

AbstractPurposeQuantitative MRI enables direct quantification of contrast agent concentrations in contrast‐enhanced scans. However, the lengthy scan times required by conventional methods are inadequate for tracking contrast agent transport dynamically in mouse brain. We developed a 3D MR fingerprinting (MRF) method for simultaneous T1 and T2 mapping across the whole mouse brain with 4.3‐min temporal resolution.MethodWe designed a 3D MRF sequence with variable acquisition segment lengths and magnetization preparations on a 9.4T preclinical MRI scanner. Model‐based reconstruction approaches were employed to improve the accuracy and speed of MRF acquisition. The method's accuracy for T1 and T2 measurements was validated in vitro, while its repeatability of T1 and T2 measurements was evaluated in vivo (n = 3). The utility of the 3D MRF sequence for dynamic tracking of intracisternally infused gadolinium‐diethylenetriamine pentaacetic acid (Gd‐DTPA) in the whole mouse brain was demonstrated (n = 5).ResultsPhantom studies confirmed accurate T1 and T2 measurements by 3D MRF with an undersampling factor of up to 48. Dynamic contrast‐enhanced MRF scans achieved a spatial resolution of 192 × 192 × 500 μm3 and a temporal resolution of 4.3 min, allowing for the analysis and comparison of dynamic changes in concentration and transport kinetics of intracisternally infused Gd‐DTPA across brain regions. The sequence also enabled highly repeatable, high‐resolution T1 and T2 mapping of the whole mouse brain (192 × 192 × 250 μm3) in 30 min.ConclusionWe present the first dynamic and multi‐parametric approach for quantitatively tracking contrast agent transport in the mouse brain using 3D MRF.

01 Nov 2024·Nanomedicine: Nanotechnology, Biology and Medicine

Nanostructured gadolinium(III) micelles: Synthesis, characterization, cytotoxic activities, and MRI applications in vivo

Article

Author: Paiva, Fernando F ; Colnago, Luiz Alberto ; Dittz, Dalton ; Demicheli, Cynthia ; Islam, Arshad ; Frézard, Frederic ; Lopes, Miriam Tereza Paz ; Riaz, Fakhra ; Duarte, Erica Coelho ; da Silva, Simone Rodrigues ; de Tótaro, Priscila I S ; Mendes, Eduardo M A M

Gadolinium-based contrast agents (GBCAs) are used in around 40 % of MRI procedures. Despite initial perceptions of minimal risk, their long-term use has emphasized the need to reduce toxicity and develop more efficient GBCAs with extended blood retention. Advancements in nanomaterials have led to improved GBCAs, enhancing MRI diagnostics. This study synthesizes and characterizes nanostructured gadolinium(III) micelles as superior MRI contrast agents. The complexes, [Gd(L)2], where L is a ligand of the N-alkyl-N-methylglucamine surfactant series (L8, L10 or L12, L10), form nanostructured micelles in aqueous solution. Gd(L8)2 and Gd(L10)2 relaxivities remained stable across concentrations. Compared to Gd-DTPA, Gd(III) micelles showed enhanced T1-weighted MRI contrast. Gd(L12)2 micelles exhibited cytotoxicity against B16F10 melanoma cells (IC₅₀ 42.5 ± 2.2 μM) and L292L929 fibroblasts (IC₅₀ 52.0 ± 2.5 μM), with a selectivity index of 1.2. In vivo application in mice brain T2-weighted images suggests nanostructured Gd(III) micelles are promising MRI contrast agents for targeting healthy organs or tumors.

18 Oct 2024·European radiology experimental

Gadolinium-based coronary CT angiography on a clinical photon-counting-detector system: a dynamic circulating phantom study.

Article

Author: Emrich, Tilman ; Vecsey-Nagy, Milan ; O'Doherty, Jim ; Kuetting, Daniel ; Attenberger, Ulrike ; Gnasso, Chiara ; Luetkens, Julian A ; Schmidt, Bernhard ; Schoepf, U Joseph ; Tremamunno, Giuseppe ; Zhang, Andrew ; Kravchenko, Dmitrij ; Varga-Szemes, Akos

BACKGROUNDCoronary computed tomography angiography (CCTA) offers non-invasive diagnostics of the coronary arteries. Vessel evaluation requires the administration of intravenous contrast. The purpose of this study was to evaluate the utility of gadolinium-based contrast agent (GBCA) as an alternative to iodinated contrast for CCTA on a first-generation clinical dual-source photon-counting-detector (PCD)-CT system.METHODSA dynamic circulating phantom containing a three-dimensional-printed model of the thoracic aorta and the coronary arteries were used to evaluate injection protocols using gadopentetate dimeglumine at 50%, 100%, 150%, and 200% of the maximum approved clinical dose (0.3 mmol/kg). Virtual monoenergetic image (VMI) reconstructions ranging from 40 keV to 100 keV with 5 keV increments were generated on a PCD-CT. Contrast-to-noise ratio (CNR) was calculated from attenuations measured in the aorta and coronary arteries and noise measured in the background tissue. Attenuation of at least 350 HU was deemed as diagnostic.RESULTSThe highest coronary attenuation (441 ± 23 HU, mean ± standard deviation) and CNR (29.5 ± 1.5) was achieved at 40 keV and at the highest GBCA dose (200%). There was a systematic decline of attenuation and CNR with higher keV reconstructions and lower GBCA doses. Only reconstructions at 40 and 45 keV at 200% and 40 keV at 150% GBCA dose demonstrated sufficient attenuation above 350 HU.CONCLUSIONCurrent PCD-CT protocols and settings are unsuitable for the use of GBCA for CCTA at clinically approved doses. Future advances to the PCD-CT system including a 4-threshold mode, as well as multi-material decomposition may add new opportunities for k-edge imaging of GBCA.RELEVANCE STATEMENTPatients allergic to iodine-based contrast media and the future of multicontrast CT examinations would benefit greatly from alternative contrast media, but the utility of GBCA for coronary photon-counting-dector-CT angiography remains limited without further optimization of protocols and scanner settings.KEY POINTSGBCA-enhanced coronary PCD-CT angiography is not feasible at clinically approved doses. GBCAs have potential applications for the visualization of larger vessels, such as the aorta, on PCD-CT angiography. Higher GBCA doses and lower keV reconstructions achieved higher attenuation values and CNR.

News (Medical) associated with Gadopentetate Dimeglumine

09 May 2023

·www.biospace.com

Guerbet Announces ACR Committee on Drugs and Contrast Media Classifies Elucirem™ (Gadopiclenol) Injection a Group II Agent

Elucirem™, a Novel New Macrocyclic GBCA for Use in Contrast-Enhanced Magnetic Resonance Imaging (MRI), has the highest relaxivity compared to other non-specific GBCAs (gadolinium-based contrast agents) 1 Elucirem™ requires only half the gadolinium dose of conventional non-specific GBCAs, addressing practitioners' concerns about gadolinium exposure. 2,3 PRINCETON, N.J., May 9, 2023 /PRNewswire/ -- Guerbet, a global leader in medical imaging with more than 30 years of experience in MRI, announced today that based on the most recent scientific and clinical evidence, the ACR Committee on Drugs and Contrast Media has classified Elucirem™ (gadopiclenol) as a Group II agent.6 This next generation GBCA from Guerbet, highly stable macrocyclic gadolinium-based contrast agent (GBCA), has the highest relaxivity in its class for magnetic resonance imaging (MRI) and is indicated for use in adults and children aged 2 years and older.1,4 Elucirem™ requires only half the gadolinium dose of conventional non-specific GBCAs, addressing practitioners' concerns about gadolinium exposure.2,3 "This new classification from the ACR is a real game changer for the future of Elucirem™," said Jared Houk, Commercial Vice President at Guerbet. "This is an important moment for our team as it really shows the benefit of this product and its potential in the market." The classification states that gadopiclenol "demonstrates kinetic stability and a long dissociation half-life that are comparable to other Group II macrocyclic agents. Based on the most recent scientific and clinical evidence, the ACR Committee on Drugs and Contrast Media considers the risk of NSF among patients exposed to standard or lower than standard doses of Gadopiclenol is sufficiently low or possibly nonexistent such that it has been classified as a Group II agent."6 Elucirem™ (Gadopiclenol) injection is used to detect and visualize lesions with abnormal vascularity in the central nervous system (brain, spine, and associated tissues) and the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system).1 Guerbet received FDA approval of Elucirem™ (NDA 216986) on September 21, 2022 after priority review, a designation assigned to applications for drugs that provide significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions compared to available therapies.5 GBCAs improve the contrast between lesions and surrounding tissues by accelerating the relaxation of protons thanks to interaction with gadolinium atoms. Gadopiclenol, the active drug substance of Elucirem™, has been designed to enable twice as much interaction, resulting in the highest relaxivity among all non-specific GBCAs.4 This allows use at half the conventional gadolinium dose to reveal high quality images. Elucirem is manufactured by Liebel-Flarsheim™ Company LLC, a Guerbet Group company, in Raleigh, North Carolina. About Guerbet At Guerbet, we build lasting relationships so that we enable people to live better. That is our purpose. We are a global leader in medical imaging, offering a comprehensive range of pharmaceutical products, medical devices, and digital and AI solutions for diagnostic and interventional imaging. As pioneers in contrast products for over 95 years, with more than 2,600 employees worldwide, we continuously innovate and devote 8%-10% of our revenue to research and development in five centers in France, Israel, and the United States. Guerbet (GBT) is listed on Euronext Paris (segment B – mid caps) and generated €732 million in revenue in 2021. For more information, please visit . About Gadopiclenol Gadopiclenol, initially invented by Guerbet with subsequent contribution of Bracco intellectual property, is a new macrocyclic gadolinium-based contrast agent (GBCA) with high relaxivity. The efficacy and safety of Gadopiclenol have been evaluated in MRI of the central nervous system (brain, spine, and associated tissues) and the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system) in adult and pediatric patients aged 2 years and older. (refer to the approved USPI for full information). Details on Phase III clinical trials are available on : Efficacy and Safety of Gadopiclenol for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI) Full Text View - ClinicalTrials.gov Efficacy and Safety of Gadopiclenol for Body Magnetic Resonance Imaging (MRI) - Full Text View - ClinicalTrials.gov Gadopiclenol is currently in the process of examination by the European Medicines Agency. Forward-looking statements This press release may contain statements of a forward-looking nature, based on assumptions and predictions made by the management of Guerbet group. Various known and unknown risks, uncertainties and other factors could lead to marked differences between the future results, financial situation, development and performances of the company, and the estimates made here. These factors include those mentioned in the public reports of Guerbet, available on its website . The company assumes no responsibility whatsoever in relation to the updating of these forward-looking statements, or how they correspond to future events or developments. ELUCIREM™ (gadopiclenol) injection Important Safety Information Indications and Usage ELUCIREM™ (gadopiclenol) injection is indicated in adult and pediatric patients 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 associated tissues), and the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system). Contraindications History of hypersensitivity reactions to ELUCIREM Warnings and Precautions Nephrogenic Systemic Fibrosis: GBCAs increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of GBCAs among these patients unless the diagnostic information is essential and not available with non-contrast MRI or other modalities. The GBCA-associated NSF risk appears highest for patients with chronic, severe kidney disease as well as patients with acute kidney injury. Hypersensitivity Reactions: With GBCAs, serious hypersensitivity reactions have occurred. In most cases, initial symptoms occurred within minutes of GBCA administration and resolved with prompt emergency treatment. Before ELUCIREM administration, assess all patients for any history of a reaction to contrast media, bronchial asthma and/or allergic disorders. These patients may have an increased risk for a hypersensitivity reaction to ELUCIREM. Gadolinium Retention: Gadolinium is retained for months or years in several organs. Linear GBCAs cause more retention than macrocyclic GBCAs. Consequences of gadolinium retention in the brain have not been established. Pathologic and clinical consequences of GBCA administration and retention in skin and other organs have been established in patients with impaired renal function. While clinical consequences of gadolinium retention have not been established in patients with normal renal function, certain patients might be at higher risk. These include patients requiring multiple lifetime doses, pregnant and pediatric patients, and patients with inflammatory conditions. Consider the retention characteristics of the agent when choosing a GBCA for these patients. Minimize repetitive GBCA imaging studies, particularly closely spaced studies when possible Acute Kidney Injury: In patients with chronically reduced renal function, acute kidney injury requiring dialysis has occurred with the use of GBCAs. The risk of acute kidney injury may increase with increasing dose of the contrast agent. Do not exceed the recommended dose. Extravasation and Injection Site Reactions: Injection site reactions such as injection site pain have been reported in the clinical studies with ELUCIREM. Extravasation during ELUCIREM administration may result in tissue irritation. Ensure catheter and venous patency before the injection of ELUCIREM. Interference with Visualization of Lesions Visible with Non-Contrast MRI: As with any GBCA, ELUCIREM may impair the visualization of lesions seen on non-contrast MRI. Therefore, caution should be exercised when Gadopiclenol MRI scans are interpreted without a companion non-contrast MRI scan. Adverse Reactions: In clinical trials, the most frequent adverse reactions that occurred in > 0.2% of patients who received ELUCIREM included: injection site pain, headache, nausea, injection site warmth, injection site coldness, dizziness, and localized swelling. Adverse reactions that occurred with a frequency ≤ 0.2% in patients who received 0.05 mmol/kg BW ELUCIREM included: maculopapular rash, vomiting, worsened renal impairment, feeling hot, pyrexia, oral paresthesia, dysgeusia, diarrhea, pruritus, allergic dermatitis, erythema, injection site paresthesia, Cystatin C increase, and blood creatinine increase. Use in Specific Populations Pregnancy: GBCAs cross the human placenta and result in fetal exposure and gadolinium retention. There are no available data on ELUCIREM use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Lactation: There are no data on the presence of ELUCIREM in human milk, the effects on the breastfed infant, or the effects on milk production. However, published lactation data on other GBCAs indicate that 0.01 to 0.04% of the maternal gadolinium dose is excreted in breast milk. Pediatric Use: The safety and effectiveness of ELUCIREM have not been established in pediatric patients younger than 2 years of age. Geriatric Use: This drug is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Renal Impairment: In patients with renal impairment, the exposure of gadopiclenol is increased compared to patients with normal renal function. This may increase the risk of adverse reactions such as nephrogenic systemic fibrosis (NSF). Avoid use of GBCAs among these patients unless the diagnostic information is essential and not available with non-contrast MRI or other modalities. No dose adjustment of ELUCIREM is recommended for patients with renal impairment. ELUCIREM can be removed from the body by hemodialysis You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. Please see the full Prescribing Information, including the Medication Guide, for additional important safety information. Contacts: Guerbet Leeann Essai, Head of Marketing, North America 609-480-9850/ leeann.essai@guerbet.com Syneos Health Edie Elkinson, Media Relations 310-430-6838/ edie.elkinson@syneoshealth.com

Phase 3Drug ApprovalNDAPriority Review

01 Mar 2023

·www.biospace.com

GE HealthCare Announces Completion of Phase I Subject Recruitment in Early Clinical Development Program for a First-of-its-Kind Macrocyclic Manganese-Based MRI Contrast Agent

Novel manganese-based macrocyclic Magnetic Resonance Imaging (MRI) agent could offer an alternative to gadolinium-based agents Manganese is a trace element naturally occurring in, and efficiently eliminated from, the human body The clinical trial program demonstrates GE HealthCare’s commitment to innovation in contrast media and to building a portfolio of MRI imaging agents to address radiologists’ needs for their patients CHALFONT ST GILES, England--(BUSINESS WIRE)-- GE HealthCare has today announced, at the European Congress of Radiology (ECR) in Vienna, Austria, the completion of Phase I subject recruitment in its early clinical development program for a first-of-its-kind manganese-based macrocyclic magnetic resonance imaging (MRI) contrast agent. Typically, MRI agents – used to enhance visualization of abnormal structures or lesions and to aid differentiation between healthy and pathological tissue – are gadolinium-based. This manganese-based agent could broaden GE HealthCare’s portfolio of MRI contrast agents available to radiologists, providing a potential alternative in light of perceived concerns relating to gadolinium retention. This press release features multimedia. View the full release here: GE HealthCare is innovating in contrast media (Photo: Business Wire) The macrocyclic, extra-cellular – or general-purpose – manganese-based contrast agent has comparable relaxivity - the ability of a contrast agent to enhance signal intensity during an MRI scan - and is expected to be diagnostically similar to current gadolinium-based contrast agents (GBCAs). Unlike gadolinium, manganese is endogenous, meaning that it is a trace element that is naturally occurring in and efficiently eliminated from the body. Along with its magnetic properties, this makes a manganese-based agent a viable alternative to gadolinium. In addition, a non-gadolinium agent could help limit the potential impact of post-patient excreted gadolinium in the environment. The clinical trial, based at the clinical research unit at the Oslo University Hospital, Rikshospitalet, Norway, and overseen by Lead Investigator, Hasse K. Zaré, aims to investigate the safety pro how this injectable manganese contrast agent is eliminated from the body in healthy volunteers. Previous manganese-based MRI agents have been reliant on a ‘free manganese’ release mechanism for their imaging efficacy. This novel investigational agent is tightly bound to the chelate, in a macrocyclic cage-like structure, so it is rapidly eliminated from - rather than actively released into - the body. Dr Paul Evans, Head of Global R&D at GE HealthCare’s Pharmaceutical Diagnostics unit, said: “For many years we’ve been committed to investing in, and bringing to market, products to help solve some of radiology’s biggest challenges and unmet needs. This manganese-based MRI agent is one of a number of novel agents we have at various stages of development in our innovation pipeline, all of which aim to give practitioners more choice in delivering precision care for their patients.” GE HealthCare’s Pharmaceutical Diagnostics unit is a global leader in imaging agents used to support around 100 million procedures per year globally, equivalent to three patient procedures every second. For more than 40 years, GE imaging agents have been routinely used across MRI, X-ray/CT and ultrasound to enhance clinical images and support diagnosis. About GE HealthCare Technologies Inc. GE HealthCare is a leading global medical technology, pharmaceutical diagnostics, and digital solutions innovator, dedicated to providing integrated solutions, services, and data analytics to make hospitals more efficient, clinicians more effective, therapies more precise, and patients healthier and happier. Serving patients and providers for more than 100 years, GE HealthCare is advancing personalized, connected, and compassionate care, while simplifying the patient’s journey across the care pathway. Together our Imaging, Ultrasound, Patient Care Solutions, and Pharmaceutical Diagnostics businesses help improve patient care from diagnosis, to therapy, to monitoring. We are a $18.3 billion business with 50,000 employees working to create a world where healthcare has no limits. Follow us on Facebook, LinkedIn, Twitter, and Insights for the latest news, or visit our website for more information. View source version on businesswire.com: Contacts GE HealthCare Media: Mathilde Bouscaillou M +3364 700 8271 Mathilde.Bouscaillou@ge.com Source: GE HealthCare Smart Multimedia Gallery Photo GE HealthCare is innovating in contrast media (Photo: Business Wire) Logo View this news release and multimedia online at:

Phase 1

28 Feb 2023

·www.biospace.com

Ascelia Pharma meets major milestone with patient enrollment completion of Phase 3 Study for Orviglance, novel MRI contrast agent for patients with kidney impairment

Ascelia Pharma AB (publ) (ticker: ACE), a biotech focused on improving the life of people living with rare cancer conditions, today announced the successful completion of patient enrollment in the company’s pivotal phase 3 clinical study, SPARKLE, with the lead candidate drug Orviglance®. “We are very pleased to have reached our enrollment target of 80 patients. This is a major milestone in the history of Ascelia Pharma and a key step on the journey to making Orviglance available to patients around the world. The focus will now switch to the evaluation of MRI images by independent radiologists, as required by regulatory standards, and the headline results from this pivotal study are expected in mid-2023”, said Magnus Corfitzen, CEO of Ascelia Pharma. Orviglance, which has been granted an Orphan Drug Designation by the US Food and Drug Administration (FDA), is the first contrast agent in development for use in liver magnetic resonance imaging (MRI) in patients with severely impaired kidney function. Cancer can be difficult to diagnose and treat because of its ability to metastasize - spread beyond the location of the primary tumor. The liver is the second most likely organ for metastases to develop, playing a significant role in the demise of patients diagnosed with breast or colorectal cancer. MRI is usually the preferred imaging modality for both initial cancer disease staging and monitoring of liver metastases and relies on contrast agents to improve the quality of the obtained scan. However, the standard MRI contrast agents currently available contain the heavy metal gadolinium, which when used in patients with impaired kidney function can increase the risk of the serious and potentially fatal condition, Nephrogenic Systemic Fibrosis (NSF). For this reason, regulatory bodies have issued warnings for their use in this patient population and patients with severe kidney impairment typically have an MRI without contrast enhancement, which reduces image quality and ability to detect and localize cancer tumors or metastases. Ascelia Pharma’s SPARKLE study aims to demonstrate that Orviglance improves the detection and visualization of focal liver lesions, including liver metastases and primary tumors, in patients with severe kidney impairment. The SPARKLE study is the last of nine studies in the extensive clinical development program for Orviglance, which will enable Ascelia Pharma to complete a New Drug Application (NDA) submission to the FDA. Orviglance aims to give cancer patients with poor kidney function access to safe and effective liver imaging to live longer and healthier lives. The unmet need for these patients represents an addressable market potential of USD 500-600 million in the US, Europe and Japan. “On behalf of the entire Ascelia Pharma team, I would like to thank patients, investigators, and other collaborators who have been involved in SPARKLE. We have succeeded in enrolling 80 patients in a rare disease clinical study under highly challenging circumstances, including a global pandemic and the invasion of Ukraine. Based on strong results in earlier clinical studies, we are optimistic of a positive outcome of SPARKLE and look forward to the next steps in bringing Orviglance through the regulatory process and making it available to patients for whom the use of gadolinium-based products may be medically inadvisable”, said Magnus Corfitzen. Contacts Media contact: Hannah Steele Email: hls@scottpr.com Tel: +44 1477 539 539 Magnus Corfitzen, CEO Email: moc@ascelia.com Tel: +46 735 179 118 About Us Ascelia Pharma is a biotech company focused on orphan oncology treatments. We develop and commercialize novel drugs that address unmet medical needs and have a clear development and market pathway. The company has two drug candidates – Orviglance (previously referred to as Mangoral) and Oncoral – in clinical development. Ascelia Pharma has global headquarters in Malmö, Sweden, and is listed on Nasdaq Stockholm (ticker: ACE). For more information, please visit About Orviglance (previously referred to as Mangoral) Orviglance (manganese chloride tetrahydrate) is a novel oral contrast agent for MR-imaging developed to improve the detection and visualization of focal liver lesions (including liver metastases and primary tumors) in patients with reduced kidney function. These patients are at risk of serious side effects from the currently available class of gadolinium-based contrast agents. Orviglance has been granted an Orphan Drug Designation by the US Food and Drug Administration (FDA). A clinical program of nine studies, including the global Phase 3 study SPARKLE, have been completed.

Phase 3Orphan Drug

100 Deals associated with Gadopentetate Dimeglumine

External Link

KEGG	Wiki	ATC	Drug Bank
D01707	Gadopentetate Dimeglumine	V08CA01	DB00789

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Contrast agents	CN	Guangzhou Consun Pharmaceutical Co., Ltd.	01 Jan 1995

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Myocardial Infarction	Phase 1	US	Bayer AG	01 Mar 2006
Peripheral Arterial Disease	Phase 1	JP	Bayer AG	01 Jul 2004
vascular arterial disease	Phase 1	JP	Bayer AG	01 Jul 2004
Primary Immunodeficiency Diseases	Phase 1	US	Asis Co., Ltd.	-
Cardiovascular Abnormalities	Discovery	-	Bayer AG	01 Dec 2003
Constriction, Pathologic	Discovery	-	Bayer AG	01 Dec 2003
Renal Artery Obstruction	Discovery	-	Bayer AG	01 Dec 2003
Peripheral Vascular Diseases	Discovery	-	Bayer AG	01 Mar 2003
Brain metastases	Discovery	JP	Bayer AG	01 Feb 2003

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02057874 (CTgov)	Not Applicable	Hepatocellular Carcinoma	2	3 Tesla Magnetic Resonance Imaging+Magnevist® (Intravenous (IV) administration of MRI contrast agent)	ymmggpqdjj(gqrrgolqvp) = glppmtnidt gzcgsolkvh (blczjznobj, lsfzwwqrku - vqoekpyyhh) View more	-	11 Jul 2018
NCT00537056 (CTgov)	Not Applicable	Renal Cell Carcinoma	17	FDG PET CT+F-18 Fluoro-deoxi-glucose+sunitinib+Gadolinium-DTPA	yujibvjjgr(jgxapvcyvf) = soapltauax llwvtaccqx (zsdhkxewep, hsgmtlotbz - pbqkuraqxm) View more	-	14 Jun 2017
NCT02080312 (CTgov)	Not Applicable	Meniere Disease	6	Magnevist (gadopentetate dimeglumine)	etizuzkflc(pshacpzzdn) = qdhbwxmywk ptbzudnkta (ruiwjsevvc, nltbuxropa - bvexhyulve) View more	-	12 Feb 2016
NCT01260636 (Supra-Aortic VALUE, Pubmed \| AJNR Am J Neuroradiol)	Phase 3	-	46	Single-dose gadobenate dimeglumine	(nkmpfiquet) = yqhwupvjdc rrdkybdosx (kfsnizxdwx ) View more	Positive	01 Apr 2013
	Phase 3	-	46	Double-dose gadopentetate dimeglumine	(nkmpfiquet) = ssdawrnljb rrdkybdosx (kfsnizxdwx ) View more	Positive	01 Apr 2013
NCT00395460 (CTgov)	Phase 3	Spinal Diseases \| Central Nervous System Diseases	147	Magnevist	wqdyuhkoli(mslzyxxpyo) = otiabzkenq neesvvmxzw (fwtmbeyrlt, ehauqydihu - intkyahefq) View more	-	01 Nov 2011
NCT00486473 (DETECT, Pubmed \| Radiology)	Phase 3	Mitral Valve Insufficiency	-	Gadobenate dimeglumine	(xvwyqcgapu) = uxlucphgst puwkynrxyl (tseednupyy ) View more	Positive	01 Feb 2011
NCT00486473 (DETECT, Pubmed \| Radiology)	Phase 3	Mitral Valve Insufficiency	-	Gadopentetate dimeglumine	(xvwyqcgapu) = ncwpcdiuvj puwkynrxyl (tseednupyy ) View more	Positive	01 Feb 2011

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