This research aims to investigate whether symptoms of chest pain or shortness of breath among the study population are arising due to a heart problem, particularly any reduction of blood flow to the heart muscle from blockages in the coronary blood vessels or inflammation of the heart using cardiac magnetic resonance imaging that measures the amount of blood flow during a stress state meant to simulate vigorous exercise. At present, doctors use standard magnetic resonance imaging pictures of blood flow patterns to treat heart disease. The investigators want to study if detailed blood flow measurements, in addition to the standard blood flow pattern, could diagnose heart disease more accurately and allow more doctors to understand the severity of heart disease. Early research has demonstrated that detailed blood flow measurements may be more accurate in diagnosing heart disease in some patients, but doctors need more information to know how to use these measurements.

Start Date27 Jun 2025

Sponsor / Collaborator

The Brigham & Women's Hospital, Inc.

NCT05915702

/ 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 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

100 Clinical Results associated with Gadobutrol

100 Translational Medicine associated with Gadobutrol

100 Patents (Medical) associated with Gadobutrol

809

Literatures (Medical) associated with Gadobutrol

01 Oct 2025·EUROPEAN JOURNAL OF RADIOLOGY

Gadolinium concentration dependent signal enhancement profiles using routine clinical sequences with gadopiclenol, gadoterate, gadobutrol, and gadoxetate at 1.5, 3 and 7 Tesla

Article

Author: Froehlich, Johannes M ; Nanz, Daniel ; Sutter, Reto ; Marth, Thomas

PURPOSE:

Gadopiclenol, a new gadolinium-(Gd) based contrast agent (GBCA), exhibits a higher longitudinal relaxivity (r₁) than current standard GBCAs, and, thus, has the potential to be used at lower dose or to generate a brighter T1-weighted (T1w) signal at equivalent dose. As the relationship between enhancement and contrast agent concentration is non-linear, the signal profiles should be experimentally explored and compared to those of current GBCAs.

MATERIALS AND METHODS:

Standardized aqueous dilution series (0.0 to 25 mmol/L) of gadopiclenol, and current standard GBCAs gadoterate, gadobutrol, and gadoxetate were imaged with nine clinical sequences at 1.5, 3, and 7 Tesla(T). Signal intensities(SIs) were measured for each concentration and set in relation to the SI of water(rSI). Additionally, T1 relaxation times were measured at 3 T and r₁ was calculated.

RESULTS:

The maximum rSI in T1w fast-spin-echo images was observed at a lower Gd concentration (1.0 mmol/L) at all three field strengths in the gadopiclenol series than in the current standard GBCAs series (gadoterate and gadobutrol, 2.5 mmol/L, all field strengths, gadoxetate, 2.5 mmol/L at 1.5 and 3 T, 1.0 and 2.5 mmol/L at 7 T). The maximum rSI measured at 1.0 mmol/l gadopiclenol was comparable (±12 %rSI) to the rSI at 2.5 mmol/l of standard GBCAs. Molar gadopiclenol relaxivity, r₁, (13.5 ± 1.5 s^-1∙mM^-1) was three to four times higher than r₁ of gadoterate and gadobutrol (3.4 ± 0.4 and 4.1 ± 0.5 s^-1∙mM^-1, respectively), and 2.2 times higher than of that of gadoxetate (6.0 ± 0.7 s^-1∙mM^-1).

CONCLUSION:

Our results confirm the maximum signal intensity in clinical T1w images to be shifted to lower gadolinium concentrations of gadopiclenol compared to standard GBCAs at all field strengths.

01 Sep 2025·STROKE

Investigation of Poststroke Depression Following a Nucleus Accumbens Infarct in Mice

Article

Author: Collignon, Adeline ; Ménard, Caroline ; Dion-Albert, Laurence ; Daigle, Béatrice ; Lévesque, Martin ; Desjardins, Michèle ; Rioux, Véronique ; St-Arnault, Vincent ; Menegatti Bevilacqua, Laura ; Bandeira Binder, Luisa ; Bouchard, Jonathan ; Lebel, Manon

BACKGROUND::

Poststroke depression (PSD) affects ≈33% of individuals 1 year after a stroke. Blood-brain barrier (BBB) dysfunction in the nucleus accumbens (NAc), a hub for emotional processing, reward, and mood regulation, has been linked to stress-induced depressive-like behaviors in male mice. Neurovascular alterations were also observed in postmortem tissue samples from men with a diagnosis of major depression. Thus, we aimed to investigate if BBB changes in the NAc could contribute to PSD pathophysiology.

METHODS::

Stereotaxic injection of ET-1 (endothelin-1), a potent vasoconstrictor, was performed in the NAc of male mice to create a focal brain stroke, and then, infarct size and localization were assessed and quantified. We subsequently evaluated transcriptomic and morphological effects of the infarct on BBB-related genes and cells in the NAc, particularly those known to be altered after stress exposure in mice or human depression. BBB integrity was assessed with a dextran dye, and magnetic resonance imaging scans were conducted before versus after the injection of Gadovist, a contrast agent. Last, a battery of behavioral tests related to depressive- and anxiety-like behaviors was performed to determine if an infarct in the NAc is sufficient to induce a PSD-like phenotype.

RESULTS::

Following ET-1 injection, ≈50% of the total lesion was observed in the NAc leading to BBB hyperpermeability in this brain area. BBB gene expression was impacted by ET-1, and also surgery alone and profiles were differentially regulated throughout time up to 14 days. Gliosis in the NAc was observed with increased reactivity of astrocytes and microglia. The effect of ET-1 on PSD-like symptoms was limited. However, body weight, sociability, and activity were affected by surgery with a more pronounced impact of ET-1 on social interactions compared with naive animals.

CONCLUSIONS::

While no clear PSD phenotype was observed following an ET-1–induced stroke in the NAc of male mice, our study shed light on the technical complexity of focal lesions in deep brain structures, an understudied phenomenon occurring in humans. We provide technical insights for the development of a mouse model of deep brain lesions, characterize its impact at molecular, cellular, and behavioral levels, and highlight the need to control for vascular alterations when performing stroke surgeries.

13 Aug 2025·MAGNETIC RESONANCE IN MEDICINE

Dynamic contrast enhanced-magnetic resonance fingerprinting (DCE-MRF): A new quantitative MRI method to reliably assess tumor vascular perfusion.

Article

Author: Wu, Chunying ; Dhakan, Chetan B ; Flask, Chris A ; Yu, Xin ; Schiemann, William P ; Pagel, Mark D ; Dupuis, Andrew ; Griswold, Mark A ; Zhu, Yuran ; Wang, Guanhua ; Kavran, Michael ; MacAskill, Christina J ; Schiemann, Barbara J ; Erokwu, Bernadette O

PURPOSE:

The clinical utility of conventional DCE-MRI methods is limited by the use of conventional qualitative dynamic T₁-weighted images, resulting in poor reproducibility. This study presents the initial implementation of a new DCE-magnetic resonance fingerprinting (DCE-MRF) methodology to provide reproducible, quantitative assessments of tumor vascular perfusion.

METHODS:

The DCE-MRF acquisition combines multiple T₁ preparations, highly undersampled spiral trajectories (R = 48), a low-rank reconstruction method, and low tip angles on a 9.4 T preclinical MRI scanner to rapidly generate dynamic T₁ maps (23-s temporal resolution). In vitro validation experiments were conducted across a range of Gadovist concentrations to assess accuracy and temporal precision in comparison to conventional methods. The DCE-MRF method was also evaluated in vivo in an orthotopic 4T1 mouse model of breast cancer (n = 25). Pharmacokinetic modeling of the in vivo data was performed using a linear reference region model (LRRM).

RESULTS:

In vitro DCE-MRF studies demonstrated good agreement with conventional MRI methods for T₁ measurements (R² __-mml:math xmlns:mml="http://www.w3.org/1998/Math/MathML"-__ ≥ $$ \ge $$ 0.99). The iterative low-rank reconstruction method also reduced artifacts compared to conventional reconstruction methods. DCE-MRF demonstrated a 2- to 3-fold reduction in temporal variability compared to conventional DCE-MRI, and enabled effective in vivo pharmacokinetic modeling using the LRRM by generating voxelwise maps of RK^trans and k_ep,T as measures of tumor vascular perfusion.

CONCLUSIONS:

DCE-MRF represents a new inherently quantitative approach to measuring tumor vascular perfusion that can be used in animal models and eventually in patients.

News (Medical) associated with Gadobutrol

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

13 Sep 2024

·www.prnewswire.com

Zydus announces exclusive licensing and supply agreement for two Gadolinium based Magnetic Resonance Imaging (MRI) injectable, contrast agents in the US

AHMEDABAD, India, Sept. 13, 2024 /PRNewswire/ -- Zydus Lifesciences Ltd., a global innovation driven healthcare company announced that its wholly owned subsidiary, Zydus Lifesciences Global FZE has entered into an exclusive licensing and supply agreement with Viwit Pharmaceuticals (Viwit), an innovation driven biopharmaceutical and healthcare company, 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 US$ 120 million, and for gadoterate meglumine injection at US$ 117 million in the US market (as per IQVIA MAT Jul - 2024). About Zydus Zydus Lifesciences Ltd. with an overarching purpose of empowering people with freedom to live healthier and more fulfilled lives, is an innovative, global lifesciences 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 lifesciences through quality healthcare solutions that impact lives. The group aspires to transform lives through path-breaking discoveries. For more details visit About Viwit Pharmaceuticals Viwit is an innovation driven biopharmaceutical and healthcare company with integrated research and development, production and marketing systems. Viwit is committed to building a platform for pharmaceutical innovation and commercialization, and establishing an ecosystem that serves the healthcare needs of the general public. Viwit started as Boranes producing company and has evolved into a healthcare company offering API and Drug Product development and manufacturing as well as CDMO services. Viwit has three integrated product R&D centers, three cGMP US FDA inspected production facilities. By continuously improving the level, depth and scope of innovation, Viwit makes every effort to provide people with better health products and services, and to fulfil Viwit vision of "Innovation for a Better Life". For more details visit . Logo: SOURCE Zydus Lifesciences Limited WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

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	havrzlsrfw(mecshprupu) = bzqozteeyk nqyhtjrqfx (fgdavjbnyw ) View more	Positive	16 Jun 2021
NCT03602339 (LEADER-75, Pubmed \| AJR Am J Roentgenol)	Phase 4	-	141	Standard Dose Gadoterate	havrzlsrfw(mecshprupu) = ywynvwnsvz nqyhtjrqfx (fgdavjbnyw ) View more	Positive	16 Jun 2021
NCT03602339 (LEADER-75 \| LEADER 75, CTgov)	Phase 4	-	157	Gadoterate (Gadoterate 0.1 mmol/kg BW)	ajclkujntg(cpefeybgyl) = kjjppsamcz lryltzpyxt (mgnbyicljo, 0.252) View more	-	28 Apr 2021
NCT03602339 (LEADER-75 \| LEADER 75, CTgov)	Phase 4	-	157	Gadobutrol (Gadobutrol 0.075 mmol/kg BW)	ajclkujntg(cpefeybgyl) = spkobvzrzh lryltzpyxt (mgnbyicljo, 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	jscrobnivt(klisevizxq) = chknuqdeix mlhdgayqgx (ssnlwsxlhp, 1.8) View more	-	08 Feb 2021
NCT01890434 (GadaCAD 2, CTgov)	Phase 3	Coronary Artery Disease	478	Gadobutrol (Gadavist, Gadovist, BAY86-4875)	ffanophyxi = fflnqtrwxk asuhfykrrx (uunjdbdvdb, vlqqldchzd - couqijmtyj) View more	-	16 May 2018
NCT01890421 (GadaCAD 1, CTgov)	Phase 3	Coronary Artery Disease	426	Gadovist	cnzdkgdstw = mxdmucqwid cyoolbbvre (tuaebnxvoh, udjmuigdpu - vliyxiosgi) View more	-	16 May 2018
NCT01095081 (GARDIAN, Pubmed \| Eur Radiol) Manual	Not Applicable	Contrast agents	23,708	gadobutrol	vphdorcnoe(sxvrjvoiif) = pexxeszixn rdplgmhhkf (ngoyxtkuuz ) View more	Positive	01 Jan 2017
NCT01104584 \| NCT01067976 (Pubmed \| Invest Radiol) Manual	Phase 3	Neoplasms	906	Gadobutrol	lqxfkjmlsk(fpwukdmjya) = 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. swcphotoux (glawlgbzyl )	Positive	01 Jul 2016
NCT01344460 (GRAMS, Biospace) Manual	Phase 3	Vascular Diseases	292	Gadobutrol	fydpuwjvdz(mrhwaiphnf) = unkztoftpu lodqthverv (qyakloqcei ) View more	Positive	29 Apr 2016
NCT01490294 (CTgov)	Phase 2	Cardiovascular Diseases	232	Gadovist (Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875))	gyhblxkzhw = metmkeqjxz ooxallnvdk (gscrbfwcck, yjtxjcqqya - cqjzhtndpf) View more	-	28 Jun 2012
NCT01490294 (CTgov)	Phase 2	Cardiovascular Diseases	232	Gadovist (Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875))	gyhblxkzhw = tmieloyfgh ooxallnvdk (gscrbfwcck, vfbhkgwkpq - kpxcekzjmz) View more	-	28 Jun 2012

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