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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

Gadobutrol / Gadavist-enhanced Cardiac Magnetic Resonance Imaging (CMRI) to Detect Coronary Artery Disease (CAD)

Phase 3
Completed
Conditions
Coronary Artery Disease
Interventions
First Posted Date
2013-07-01
Last Posted Date
2019-07-31
Lead Sponsor
Bayer
Target Recruit Count
478
Registration Number
NCT01890434

Gadobutrol/Gadavist-enhanced Cardiac Magnetic Resonance Imaging (CMRI) to Detect Coronary Artery Disease (CAD)

Phase 3
Completed
Conditions
Coronary Artery Disease
Interventions
First Posted Date
2013-07-01
Last Posted Date
2018-05-16
Lead Sponsor
Bayer
Target Recruit Count
426
Registration Number
NCT01890421

Safety and Efficacy of Gadobutrol 1.0 Molar in Japanese Subjects for CNS Imaging

Phase 3
Completed
Conditions
Magnetic Resonance Imaging
Interventions
First Posted Date
2012-08-09
Last Posted Date
2014-10-01
Lead Sponsor
Bayer
Target Recruit Count
223
Registration Number
NCT01660841

Comparison of Prohance® With Gadovist®/Gadavist™ in Magnetic Resonance Imaging (MRI) of the Brain

Phase 4
Completed
Conditions
Brain Disease
Interventions
First Posted Date
2012-06-07
Last Posted Date
2015-07-01
Lead Sponsor
Bracco Diagnostics, Inc
Target Recruit Count
229
Registration Number
NCT01613417
Locations
🇺🇸

Holy Name Medical Center, Teaneck, New Jersey, United States

Gadobutrol Pharmacokinetic and Safety Study in Pediatric Subjects Aged <2 Years (Term Newborn Infants to Toddlers 23 Months of Age Inclusive)

Phase 1
Completed
Conditions
Magnetic Resonance Imaging
Interventions
First Posted Date
2012-03-05
Last Posted Date
2020-12-16
Lead Sponsor
Bayer
Target Recruit Count
44
Registration Number
NCT01544166

Myocardial Perfusion MRI

Phase 2
Completed
Conditions
Magnetic Resonance Imaging
Myocardial Perfusion Imaging
Interventions
First Posted Date
2011-12-12
Last Posted Date
2014-05-22
Lead Sponsor
Bayer
Target Recruit Count
232
Registration Number
NCT01490294

Gadobutrol Enhanced MRA of the Renal Arteries

Phase 3
Completed
Conditions
Renal Artery Obstruction
Interventions
First Posted Date
2011-04-29
Last Posted Date
2015-08-26
Lead Sponsor
Bayer
Target Recruit Count
317
Registration Number
NCT01344460

Gadobutrol Enhanced MRA of the Supra-aortic Vessels

Phase 3
Completed
Conditions
Carotid Stenosis
Interventions
First Posted Date
2011-04-29
Last Posted Date
2019-01-04
Lead Sponsor
Bayer
Target Recruit Count
479
Registration Number
NCT01344447

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

Phase 3
Completed
Conditions
Breast Cancer
Interventions
First Posted Date
2010-04-15
Last Posted Date
2014-11-11
Lead Sponsor
Bayer
Target Recruit Count
460
Registration Number
NCT01104584

GARDIAN, Gadovist in Routine Diagnostic Magnetic Resonance Imaging Administration in Non-selected Patients

Completed
Conditions
Magnetic Resonance Imaging
Magnetic Resonance Angiography
Interventions
First Posted Date
2010-03-29
Last Posted Date
2015-01-21
Lead Sponsor
Bayer
Target Recruit Count
23775
Registration Number
NCT01095081
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