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Gadobutrol

Generic Name
Gadobutrol
Brand Names
Gadavist, Gadovist
Drug Type
Small Molecule
Chemical Formula
C18H31GdN4O9
CAS Number
770691-21-9
Unique Ingredient Identifier
1BJ477IO2L
Background

Intravenous gadobutrol is a second-generation extracellular non-ionic macrocyclic GBCA (gadolinium-based contrast agent) used in magnetic resonance imaging (MRI) in adults and children older than 2 years of age. It may help visualize and detect vascular abnormalities in the blood brain barrier (BBB) and central nervous system (CNS).

In patients with impaired renal function, gadolinium based contrast agents increase the risk of nephrogenic systemic fibrosis (NSF). A physician should be contacted if symptoms of NSF are encountered, such as dark or red patches on the skin; stiffness in joints; trouble moving, bending or straightening arms, hands, legs or feet; burning, itching, swelling, scaling, hardening and tightening of skin; pain in hip bones or ribs; or muscle weakness.

Common adverse reactions that may be experienced include headache, nausea, feeling hot, abnormal taste, and warmth, burning or pain local to the injection site.

General precautions should be taken in patients who are pregnant or breastfeeding, or who have a history of allergic reaction to contrast media, bronchial asthma or an allergic respiratory disorder.

Indication

Gadobutrol is indicated for use with magnetic resonance imaging for the following diagnostic processes:

Associated Conditions
Arterial Occlusive Diseases of the Supra-aortic arteries, Coronary Artery Disease (CAD), Malignant Breast Neoplasm, Renal artery occlusion

Efficacy and Safety of Gadobutrol 1.0 Molar (Gadovist) for Breast MRI

Phase 3
Completed
Conditions
Breast Cancer
Diagnostic Imaging
Interventions
First Posted Date
2010-02-12
Last Posted Date
2014-11-11
Lead Sponsor
Bayer
Target Recruit Count
446
Registration Number
NCT01067976

Gadobutrol Magnevist-controlled Body Study

Phase 3
Completed
Conditions
Magnetic Resonance Imaging
Interventions
First Posted Date
2010-01-15
Last Posted Date
2014-12-30
Lead Sponsor
Bayer
Target Recruit Count
370
Registration Number
NCT01050829

Efficacy Evaluation of Dotarem Compared to Gadovist in the Diagnosis of Peripheral Arterial Disease

Phase 4
Completed
Conditions
Peripheral Arterial Disease
Interventions
First Posted Date
2009-12-04
Last Posted Date
2012-12-11
Lead Sponsor
Guerbet
Target Recruit Count
189
Registration Number
NCT01026389
Locations
🇦🇹

AKH hospital, Wien, Austria

Study to Compare MultiHance With Gadovist in Magnetic Resonance Imaging (MRI) of the Brain

Phase 4
Completed
Conditions
Brain Lesions
Interventions
First Posted Date
2009-05-22
Last Posted Date
2012-01-05
Lead Sponsor
Bracco Diagnostics, Inc
Target Recruit Count
121
Registration Number
NCT00907530
Locations
🇨🇦

Hamilton Health Sciences Corporation, Hamilton, Ontario, Canada

Observational Study on the Safety and Tolerability of Gadobutrol (Gadovist) Among Filipino Patients in Magnetic Resonance Imaging

Completed
Conditions
Magnetic Resonance Imaging
Interventions
First Posted Date
2009-05-21
Last Posted Date
2013-04-26
Lead Sponsor
Bayer
Target Recruit Count
30
Registration Number
NCT00905879

Safety of Gadovist in Renally Impaired Patients

Phase 4
Completed
Conditions
Fibrosis
Renal Impairment
Interventions
First Posted Date
2009-01-26
Last Posted Date
2016-02-18
Lead Sponsor
Bayer
Target Recruit Count
927
Registration Number
NCT00828737

Contrast-Enhanced MRI for the Characterization of Ductal Carcinoma in Situ (DCIS)

Completed
Conditions
Breast Cancer
Interventions
Procedure: Magnetic Resonance Imaging (MRI)
First Posted Date
2008-12-08
Last Posted Date
2024-01-19
Lead Sponsor
University of California, San Francisco
Target Recruit Count
76
Registration Number
NCT00804128
Locations
🇺🇸

University of California, San Francisco, San Francisco, California, United States

Contrast Enhanced MRI of the CNS - Patients With Known Cerebral Neoplastic Lesions.

Phase 4
Completed
Conditions
Neoplastic CNS Lesions
Interventions
First Posted Date
2008-10-02
Last Posted Date
2014-12-05
Lead Sponsor
Bayer
Target Recruit Count
166
Registration Number
NCT00764387

Safety and Efficacy of Gadobutrol 1.0 Molar (Gadavist) in Patients for Central Nervous System (CNS) Imaging

Phase 3
Completed
Conditions
Diagnostic Imaging
Central Nervous System Diseases
Interventions
First Posted Date
2008-07-03
Last Posted Date
2014-12-30
Lead Sponsor
Bayer
Target Recruit Count
402
Registration Number
NCT00709852
Locations
🇮🇳

Piramal Diagnostic- Jankharia Imaging, Mumbai, Maharashtra, India

🇩🇪

Universitätsklinikum Erlangen, Erlangen, Bayern, Germany

🇩🇪

LMU Klinikum der Universität München - Großhadern, München, Bayern, Germany

and more 76 locations

Safety and Efficacy of Gadobutrol 1.0 Molar ( Gadavist ) in Patients for Central Nervous System (CNS) Imaging

Phase 3
Completed
Conditions
Central Nervous System Diseases
Interventions
First Posted Date
2008-02-26
Last Posted Date
2014-02-10
Lead Sponsor
Bayer
Target Recruit Count
343
Registration Number
NCT00623467
Locations
🇰🇷

Seoul National University Hospital, Seoul, Korea, Republic of

🇺🇸

University of South Florida, Tampa, Florida, United States

🇦🇷

Centro de Diagnóstico Dr. Enrique Rossi, Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina

and more 34 locations
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