A Prospective, Multicenter Phase 2/3 Study to Assess the Efficacy and Safety of Mangaciclanol in Adult Patients With Known or Highly Suspected Lesions Referred for Contrast-Enhanced Magnetic Resonance Imaging (MRI) of Central Nervous System (CNS) or Body (LUMINA)

This is an operationally combined Phase 2/3 study, which will be conducted and evaluated in 2 distinct parts:
* Phase 2: Prospective, adaptive, multicenter, non-randomized, single-blind, dose-finding, including participants with known or highly suspected lesions of the CNS. The aim of the Phase 2 part is to identify an optimized dose of mangaciclanol for the Phase 3 part of the study.
* Phase 3: Prospective, multicenter, randomized, controlled, single-blind, cross-over, including participants with known or highly suspected lesions of the CNS or body. The aim of the Phase 3 part is to further evaluate the efficacy and safety of mangaciclanol-enhanced MRI for the detection and characterization of lesions of the CNS or body.
The investigational medicinal products (IMPs) used during the trial are mangaciclanol and gadobutrol (comparator IMP).
Primary and key secondary efficacy analyses will be based on independent central blinded image evaluation (BIE), and Phase 2 data will be analyzed prior to commencement of Phase 3.

Start Date31 Mar 2026

Sponsor / Collaborator

GE Healthcare Technologies, Inc.

NCT07275814

/ RecruitingPhase 3

A Multicenter, Randomized, Double-Blind, Positive-Controlled, Cross-Over Phase Ⅲ Clinical Trial Evaluating the Efficacy and Safety of HRS-9231 for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)

The purpose of this study is to evaluate the efficacy and safety of HRS-9231 for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI); to demonstrate that, in patients requiring CNS MRI examinations, HRS-9231 is non-inferior to Gadobutrol in lesion visualization scores and show that, in patients requiring CNS MRI examinations, contrast-enhanced MRI with HRS-9231 is superior to unenhanced MRI in lesion visualization scores using the patients as their own controls; and to explore the population pharmacokinetic characteristics of HRS-9231 in CNS MRI subjects.

Start Date17 Nov 2025

Sponsor / Collaborator

Shanghai Shengdi Pharmaceutical Co., Ltd.

100 Clinical Results associated with Gadobutrol

100 Translational Medicine associated with Gadobutrol

100 Patents (Medical) associated with Gadobutrol

794

Literatures (Medical) associated with Gadobutrol

01 Apr 2026·MAGNETIC RESONANCE IN MEDICINE

Optimized Magnetic Resonance T1 Mapping for Estimation of Intrathecal Contrast Concentrations in Human Brain and Ventricular Cerebrospinal Fluid

Article

Author: Vatnehol, Svein Are Sirirud ; Storås, Trygve Holck ; Ringstad, Geir ; Emblem, Kyrre Eeg ; Valnes, Lars Magnus ; Eide, Per Kristian

ABSTRACT:

Purpose:

Intrathecal contrast‐enhanced magnetic resonance imaging (MRI), which uses a contrast agent as a cerebrospinal fluid (CSF) tracer, is an emerging technique for in vivo imaging of glymphatic function in humans. T1 mapping enables quantification of tracer concentrations; however, methodological limitations persist. This study aimed to enhance the utility of a standard Look‐Locker MRI sequence for quantifying tracer concentrations in both brain parenchyma and ventricular CSF.

Methods:

Using a 3 T MRI scanner, we conducted (i) optimization of a Look‐Locker T1 mapping protocol to determine T1 relaxation times in brain parenchyma and ventricular CSF, (ii) a phantom study to assess repeatability of T1 times estimation and the relaxivity constant r1 calculation, and (iii) a feasibility assessment in patients.

Results:

An optimized Look‐Locker protocol for T1 mapping enabled estimation of T1 relaxation times in brain parenchyma and ventricular CSF that compare with previously reported T1 times. The phantom study demonstrated repeatability of T1 time estimations. In six patients with idiopathic normal pressure hydrocephalus, the method proved feasible for estimating CSF tracer concentrations in brain and ventricular CSF over time following intrathecal MRI contrast injection (gadobutrol, 0.5 mmol).

Conclusion:

Optimizing a standard Look‐Locker T1 mapping protocol allowed for estimation of reliable T1 times in both brain parenchyma and ventricular CSF, and the subsequent determination of concentrations of intrathecal CSF tracer in the human brain, supporting its potential for studying glymphatic function. However, limitations with estimation of T1 times and the selection of relaxivity constant of the contrast agent reduce accuracy of concentration estimates.

10 Mar 2026·ACS Nano

Predicting Plaque Vulnerability Using Machine Learning-Enabled Nanoagents Sensitized Molecular High-Resolution Magnetic Resonance Imaging Data

Article

Author: Wu, Menglin ; Fu, Dingwei ; Yang, Weitao ; Xia, Shuang ; Li, Jiang ; Zhao, Yang ; Zhao, Xunxiao ; Zhang, Xuening ; Gong, Yan ; Zhang, Xiang ; Zhang, Bingbo ; Li, Xue

Molecular imaging based on paramagnetic nanoagents has emerged as an intriguing strategy to sensitize the local magnetic properties of pivotal pathological processes related to atherosclerotic plaque destabilization, opening up a potential possibility for noninvasively predicting plaque vulnerability. Unfortunately, current magnetic resonance (MR) imaging interpretation fails to provide objectively and precisely quantitative imaging descriptors, thus showing limited values in stratifying the plaque risk from MR images. To address this need, we originated a synergistic nanoagents (tFM-Nanoagents)-assisted machine learning (nano-AML) technology for directly reading out plaque vulnerability from molecular high-resolution vessel wall MR imaging (HR-VWI). The proposed diagnostic paradigm provided a holistic visualization of the distribution of foamy macrophage-defined plaques; by using a machine learning (ML) approach to decode data of tFM-Nanoagents sensitized HR-VWI, an imaging-derived risk score (nano-AML score) correlating with the pathology vulnerability index of plaques was generated and validated in a preclinical atherosclerotic model. Our data showed that the nano-AML score could effectively phenotype plaques into "vulnerable" and "stable" classes, with an area under the curve (AUC) of 0.871 in the training cohort and 0.870 in the validation cohort. We also demonstrated that the predictive performance of nano-AML score outperformed that of commercial contrast agent Gadovist (AUC of 0.560 in the training cohort and 0.538 in the validation cohort), suggesting its robust potency for serving as a reliable predictor for vulnerable plaques.

01 Mar 2026·JOURNAL OF MAGNETIC RESONANCE IMAGING

Betanin‐Based Contrast Agents for MRI : A Preliminary Experimental Study

Article

Author: Esen, Alperen C. ; Özsunar, Yelda ; Tataroğlu, Canten ; Bilgen, Mehmet ; Aktaş, Serdar ; Kurt, Berrak ; Kayhan, Handan

ABSTRACT:

Background:

Gadolinium‐based contrast agents (GBCAs) are used in MRI, yet concerns about gadolinium ion release, tissue retention, rare adverse events, and environmental persistence have encouraged the search for alternatives. Prior work on plant‐based extracts has been largely confined to gastrointestinal luminal imaging, with limited exploration in extraluminal organs as contrast agents.

Purpose:

To preclinically investigate the potentials of Betanin and beetroot‐derived Betanin‐based contrast agents (BBCA) in vitro and in vivo via oral, intravenous, and intraperitoneal administration, and to compare them with gadobutrol (a GBCA).

Study Type:

Prospective preclinical experimental study.

Subjects:

In vitro studies on human and mouse fibroblast cell lines, and in vivo tests involving male Wistar albino rats ( n = 15) and male New Zealand albino rabbits ( n = 2).

Field Strength/Sequence:

3 T, spin echo, and gradient echo sequences.

Assessment:

Betanin and BBCA compositions were characterized by mass spectrometry. Safety was assessed by in silico modeling, cytotoxicity, flow cytometry, histology, and blood biochemistry tests. Images of phantom solutions were used to characterize the paramagnetic features via MR relaxation times and relaxivities. In vivo contrast behavior in organs was evaluated following oral, intraperitoneal, and intravenous administrations.

Statistical Tests:

The quantitative data were analyzed with Microsoft Excel and GraphPad Prism 9.0; p value < 0.05 was significant.

Results:

Betanin had greater molecular binding efficiency and therapeutic capacity. BBCA was less cytotoxic than gadobutrol. Some elements in BBCA were present in larger amounts than Betanin. T1 and T2 decreased with an increase in BBCA concentration, and r1 and r2 were estimated as 0.0014 and 0.0224 mmol −1 s −1 , respectively. Both agents demonstrated contrast enhancements not only in the gastrointestinal lumen but also in the parenchymal organ, as well as in the vascular structure, with lower toxicity and antioxidative benefits. In particular, the enhancement in the liver was noteworthy.

Data Conclusion:

Betanin and BBCA may be considered as viable options for contrast‐enhanced abdominal MRI.

News (Medical) associated with Gadobutrol

28 Jan 2026

·www.biospace.com

The European Commission extended the Marketing Authorisation for Vueway® (gadopiclenol) in the European Union for use in pediatric patients under 2 years of age

Expanded EU approval reflects positive benefit-risk ratio of Vueway ® in children from birth MILAN , Jan. 27, 2026 /PRNewswire/ -- Bracco Imaging S.p.A., a global leader in diagnostic imaging, announces that on January 23, 2026, the European Commission (EC) amended the Marketing Authorisation for Vueway ® (gadopiclenol) in the European Union (EU), extending its approved indications to pediatric patients below 2 years of age. The extension granted by the EC followed the relevant positive opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), and the recommendation sent by EMA to the EC. (1) Vueway ® (gadopiclenol) is a novel macrocyclic gadolinium-based contrast agent (GBCA) approved in 36 countries and used to provide contrast enhancement in Magnetic Resonance Imaging (MRI) examinations, thus helping doctors find certain pathologies in patients in whom this would not be possible otherwise. (2) In the European Union (EU), Vueway ® was approved in December 2023 for its use in adults and children aged 2 years and older for contrast-enhanced MRI to improve the detection and visualization of pathologies with disruption of the blood-brain-barrier (BBB) and/or abnormal vascularity of the brain, spine, and associated tissues of the central nervous system, as well as contrast-enhanced MRI of the liver, kidney, pancreas, breast, lung, prostate, and musculoskeletal system. (3) On 11 December 2025, the CHMP adopted in EU a positive opinion for the extension of the approved indications of Vueway ® to infants and young children, including neonates, reinforcing the established safety and diagnostic performance of this new GBCA. (1) Vueway ® (gadopiclenol) is a highly stable, macrocyclic GBCA with the highest values of longitudinal relaxivity (r1) among all the currently approved GBCAs. (4) Large, multicenter clinical studies have shown that Vueway ® delivers comparable diagnostic efficacy at half the gadolinium dose of gadobutrol (5) , a GBCA widely used in clinical practice across the world. Lower-dose imaging offers the important clinical benefit of reducing exposure of patients to gadolinium. (6) "The ability to reduce exposure to gadolinium without affecting the diagnostic performance of MRI examinations is important for all patients receiving GBCAs, " said Alberto Spinazzi, Chief Medical & Regulatory Officer, Bracco Group. "This is particularly important when GBCAs are used in special patient populations, such as neonates, infants and toddlers, whose brains and body tissues are still maturing, and potential long-term effects of retained gadolinium are still unknown. Therefore, this approval on the extension of the use of Vueway ® from birth addresses a critical need." The positive CHMP opinion, the EMA recommendation, and the final EC approval were based on the results from study GDX-44-015 (study information and results are available here ). About gadolinium-based contrast agents Gadolinium-based contrast agents (GBCAs) are widely and routinely used to enhance the diagnostic performance of magnetic resonance imaging (MRI) examinations. Gadolinium is a rare earth metal that has unique magnetic properties that make it useful for the use in MRI imaging. About Bracco Imaging Bracco Imaging is a global leader in diagnostic imaging, dedicated to improving people's lives by shaping the future of prevention and precision medicine. With a strong passion for innovation, the company develops and provides a broad portfolio of pharmaceutical products for diagnostic imaging: contrast agents for X-ray, Computed Tomography (CT), and Magnetic Resonance Imaging (MRI), as well microbubbles for Contrast Enhanced Ultrasound (CEUS), and Molecular Imaging through radioactive tracers and novel PET imaging agents, alongside specialized medical devices and related services. The company is committed to advancing radiology by sharing knowledge to cultivate future thought leaders, linking today's practice with tomorrow's progress. Since 1927, Bracco Imaging has grown to more than 3,800 employees and now supports patients and radiology professionals in over 100 countries. Discover Bracco Imaging at . The Guerbet and Bracco Imaging collaboration Bracco Imaging and Guerbet in December 2021 entered a worldwide collaboration on Gadopiclenol manufacturing and research and development activities. Gadopiclenol will be commercialized independently under separate brands. Both Guerbet and Bracco Imaging each own valuable intellectual property on Gadopiclenol. Furthermore, after an agreed transition period when Guerbet manufactures Gadopiclenol for both Guerbet and Bracco, both companies will manufacture the Gadopiclenol active ingredient and finished product. The strategic collaboration is expected to accelerate access to Gadopiclenol and deliver innovation, as well as better care to patients and caregivers alike. Media Contact: Bracco Press Contact: Carolina Bargoni Bracco Imaging, Communications Director Carolina.bargoni@bracco.com References CHMP post-authorisation summary of positive opinion for Vueway (EMAVR0000249008). Available at: . Accessed on December 17, 2025. Vueway® (gadopiclenol). Overview. Available at: . Accessed on December 17, 2025. Vueway® (gadopiclenol). Summary of Product Characteristics. Available at : . Accessed on December 17, 2025. Robic C, Port M, Rousseaux O, Louguet S, Fretellier N, Catoen S, Factor C, Le Greneur S, Medina C, Bourrinet P, Raynal I, Idée JM, Corot C. Physicochemical and Pharmacokinetic Profiles of Gadopiclenol: A New Macrocyclic Gadolinium Chelate With High T1 Relaxivity. Invest Radiol 2019; 54(8):475-484. Hao J, Pitrou C, Bourrinet P. A Comprehensive Overview of the Efficacy and Safety of Gadopiclenol: A New Contrast Agent for MRI of the CNS and Body. Invest Radiol 2024; 59(2):124-130. Kanal E, Maki JH, Schramm P, Marti-Bonmati L. Evolving Characteristics of Gadolinium-Based Contrast Agents for MR Imaging: A Systematic Review of the Importance of Relaxivity. J Magn Reson Imaging 2025; 61(1):52-69. SOURCE Bracco Group

Drug Approval

15 Sep 2024

·www.pharmaindustrial-india.com

Zydus Signs Licensing and Supply Agreement with Viwit Pharmaceuticals

Zydus Lifesciences Ltd. has announced that its wholly owned subsidiary, Zydus Lifesciences Global FZE, has signed an exclusive licensing and supply agreement with Viwit Pharmaceuticals (Viwit) for gadobutrol injection (generic version of GADAVISTTM) and gadoterate meglumine injection (generic version of DOTAREM) for the US market. As per the terms of the agreement, Viwit will be responsible for ANDA submission, manufacturing and supplying the generic versions of GADAVISTTM and DOTAREM, following the receipt of requisite regulatory approval. Zydus will exclusively market, distribute, and sell these products in the US market. Both the products are Gadolinium-based Magnetic Resonance Imaging (MRI) contrast agents and will be the first set of contrast agent products in Zydus' injectable portfolio for the US market. The total addressable market opportunity for gadobutrol injection is estimated at USD 120 million and for gadoterate meglumine injection at USD 117 million in the US market. Zydus Lifesciences Ltd., with an overarching purpose of empowering people with the freedom to live healthier and more fulfilled lives, is an innovative, global life sciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The group has a significant presence in cancer-related therapies and offers a wide range of solutions with cytotoxic, supportive & targeted drugs. The group employs over 27,000 people worldwide, including 1,400 scientists engaged in R&D, and is driven by its mission to unlock new possibilities in life sciences through quality healthcare solutions that impact lives.

License out/in

15 Sep 2024

·www.pharmaindustrial-india.com

Zydus Signs Licensing and Supply Agreement with Viwit Pharmaceuticals

License out/in

100 Deals associated with Gadobutrol

External Link

KEGG	Wiki	ATC	Drug Bank
D07420	Gadobutrol	V08CA09	DB06703

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Coronary Artery Disease	United States	Bayer HealthCare Pharmaceuticals, Inc.	12 Jul 2019
Aortic Diseases	United States	Bayer HealthCare Pharmaceuticals, Inc.	27 Apr 2016
Breast Diseases	United States	Bayer HealthCare Pharmaceuticals, Inc.	29 Dec 2014
Central Nervous System Vascular Malformations	United States	Bayer HealthCare Pharmaceuticals, Inc.	14 Mar 2011
Cerebrovascular Disorders	United States	Bayer HealthCare Pharmaceuticals, Inc.	14 Mar 2011
Contrast agents	Australia	Bayer Australia Ltd.	02 Dec 1998

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Carotid Stenosis	Phase 3	United States	Bayer AG	12 May 2011
Carotid Stenosis	Phase 3	China	Bayer AG	12 May 2011
Carotid Stenosis	Phase 3	Argentina	Bayer AG	12 May 2011
Carotid Stenosis	Phase 3	Australia	Bayer AG	12 May 2011
Carotid Stenosis	Phase 3	Austria	Bayer AG	12 May 2011
Carotid Stenosis	Phase 3	Czechia	Bayer AG	12 May 2011
Carotid Stenosis	Phase 3	France	Bayer AG	12 May 2011
Carotid Stenosis	Phase 3	Germany	Bayer AG	12 May 2011
Carotid Stenosis	Phase 3	Italy	Bayer AG	12 May 2011
Carotid Stenosis	Phase 3	Poland	Bayer AG	12 May 2011

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03602339 (LEADER-75, Pubmed \| AJR Am J Roentgenol)	Phase 4	-	141	Reduced Dose Gadobutrol	scxfebzwsz(hmysvhprok) = maituptohw bajhatifqj (ngxvehmmtp ) View more	Positive	16 Jun 2021
NCT03602339 (LEADER-75, Pubmed \| AJR Am J Roentgenol)	Phase 4	-	141	Standard Dose Gadoterate	scxfebzwsz(hmysvhprok) = fkjoscmygk bajhatifqj (ngxvehmmtp ) View more	Positive	16 Jun 2021
NCT03602339 (LEADER-75 \| LEADER 75, CTgov)	Phase 4	-	157	Gadoterate (Gadoterate 0.1 mmol/kg BW)	gfdhenaceh(elugpcxzyg) = asllkfuibr kpdezabkys (nqgevriiio, 0.252) View more	-	28 Apr 2021
NCT03602339 (LEADER-75 \| LEADER 75, CTgov)	Phase 4	-	157	Gadobutrol (Gadobutrol 0.075 mmol/kg BW)	gfdhenaceh(elugpcxzyg) = inmemwhcsz kpdezabkys (nqgevriiio, 0.201) View more	-	28 Apr 2021
NCT03404648 (CTgov)	Phase 3	Advanced Prostate Carcinoma \| Adenocarcinoma of prostate	19	PET/MR scanner+C-11 choline PET tracer+Gadobutrol	uwirvntmzz(hprdywoqdg) = pidxpiwnyx mybhffwylj (bhkezxkaoe, 1.8) View more	-	08 Feb 2021
NCT01890434 (GadaCAD 2, CTgov)	Phase 3	Coronary Artery Disease	478	Gadobutrol (Gadavist, Gadovist, BAY86-4875)	urpebhgspt = ndmmmldmhb utmhsjsckd (keacwjtcyp, nczhemdoyr - cixxtdlcfk) View more	-	16 May 2018
NCT01890421 (GadaCAD 1, CTgov)	Phase 3	Coronary Artery Disease	426	Gadovist	tmcujldotm = owuvfrvfug iqzhmgldtb (ytkpcbvbsu, ibyygsyjgq - iibfkptyag) View more	-	16 May 2018
NCT01095081 (GARDIAN, Pubmed \| Eur Radiol) Manual	Not Applicable	Contrast agents	23,708	gadobutrol	vxxzdnuior(ftjldkorag) = hyvttafyzx dwgbybnowy (nxfkgxmyhw ) View more	Positive	01 Jan 2017
NCT02034708 (REMIND, CTgov)	Phase 4	Brain Cancer	279	Gadovist (Gadovist® (Reader 1))	xdpisppjns = hvhchhnret eqpqftwaik (pzviqcwqxt, owxeyioedk - qhhxncmfwb)	-	25 Oct 2016
NCT02034708 (REMIND, CTgov)	Phase 4	Brain Cancer	279	Dotarem (Dotarem® (Reader 1))	xdpisppjns = uxkfdypohn eqpqftwaik (pzviqcwqxt, uhxonoervn - woxffvhrhn)	-	25 Oct 2016
NCT01104584 \| NCT01067976 (Pubmed \| Invest Radiol) Manual	Phase 3	Neoplasms	906	Gadobutrol	xutjqecpio(eoqowhorfm) = the detection rate of malignant disease extent per patient, ranged from 80% to 89% for CE-BMRI and was significantly superior to unenhanced breast MRI alone (37%-73%) and to mammography alone (68%-73%) for all readers in both trials. qcckrnqqrw (uvlvebvpig )	Positive	01 Jul 2016
NCT01344460 (GRAMS, Biospace) Manual	Phase 3	Vascular Diseases	292	Gadobutrol	piiuaiirtf(nzbalhkefa) = xztvmcdemn mdtysbeemp (hcaeonwnqc ) View more	Positive	29 Apr 2016
NCT01490294 (CTgov)	Phase 2	Cardiovascular Diseases	232	Gadovist (Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875))	uvdcfolell = jupwucqurb qzzognltma (elrekbxzsa, vvcahqtlxb - gxpllzamey) View more	-	28 Jun 2012
NCT01490294 (CTgov)	Phase 2	Cardiovascular Diseases	232	Gadovist (Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875))	uvdcfolell = thjrnlwqbj qzzognltma (elrekbxzsa, eiibayckvu - vqenzxcphm) View more	-	28 Jun 2012

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