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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

SH L 562BB Phase II/III Dose Justification and Gadoteridol-controlled Comparative Study

Phase 3
Completed
Conditions
Brain Metastases
Interventions
First Posted Date
2007-08-30
Last Posted Date
2017-08-28
Lead Sponsor
Bayer
Target Recruit Count
165
Registration Number
NCT00522951

A Study of Magnetic Resonance Imaging (MRI) With Gadavist in Children

Phase 1
Completed
Conditions
Magnetic Resonance Imaging
Interventions
First Posted Date
2007-05-03
Last Posted Date
2015-07-22
Lead Sponsor
Bayer
Target Recruit Count
140
Registration Number
NCT00468819

Efficacy and Safety Study to Evaluate Gadavist (Gadobutrol) as Contrast Agent in Magnetic Resonance Imaging (MRI) of Brain or Spine Diseases in Chinese Patients

Phase 3
Completed
Conditions
Central Nervous System Diseases
Interventions
First Posted Date
2006-11-03
Last Posted Date
2015-06-08
Lead Sponsor
Bayer
Target Recruit Count
147
Registration Number
NCT00395460
Locations
🇨🇳

Fudan University Huashan Hospital, Shanghai, China

🇨🇳

Jiangsu Province Hospital, Nanjing, Jiangsu, China

🇨🇳

The 1st Affiliated Hosp of the 4th Military Med Uni, Xi'an, Shaanxi, China

and more 1 locations

Efficacy and Safety Study to Evaluate Gadavist (Gadobutrol) as Contrast Agent in Magnetic Resonance Imaging (MRI) of Vascular Diseases in Chinese Patients

Phase 3
Completed
Conditions
Vascular Diseases
Interventions
Drug: Gadopentate dimeglumine (Magnevist, BAY86-4882)
First Posted Date
2006-11-03
Last Posted Date
2013-12-18
Lead Sponsor
Bayer
Target Recruit Count
83
Registration Number
NCT00395733

Combined 18F-NaF/18F-FDG PET/MRI for Detection of Skeletal Metastases

Phase 2
Completed
Conditions
Cancer
Interventions
Procedure: Bone scan
Drug: 99mTc-methyl diphosphonate
Procedure: Positron Emission Tomography (PET) scan
Drug: 18F-Fludeoxyglucose (18F-FDG)
Procedure: Computed Tomography (CT) scan
Drug: 18F-Sodium Fluoride (18F-NaF)
Procedure: Whole Body Magnetic Resonance Imaging (WB-MRI) scan
First Posted Date
2006-09-13
Last Posted Date
2023-12-12
Lead Sponsor
Stanford University
Target Recruit Count
114
Registration Number
NCT00375830
Locations
🇺🇸

Stanford University School of Medicine, Stanford, California, United States

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