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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

Dotarem vs Gadobutrol Contrast for Breast MRI

Phase 4
Recruiting
Conditions
Breast Diseases
Interventions
First Posted Date
2018-11-05
Last Posted Date
2025-04-02
Lead Sponsor
University of Massachusetts, Worcester
Target Recruit Count
258
Registration Number
NCT03730051
Locations
🇺🇸

UMass Medical School, Worcester, Massachusetts, United States

Comparison of Gadovist 75% Standard Dose to Dotarem at Full Standard Dose

Phase 4
Completed
Conditions
Magnetic Resonance Imaging
Interventions
First Posted Date
2018-07-26
Last Posted Date
2021-06-14
Lead Sponsor
Bayer
Target Recruit Count
157
Registration Number
NCT03602339
Locations
🇺🇸

University of Texas Southwestern Medical Center, Dallas, Texas, United States

🇬🇧

Royal Preston Hospital, Preston, Lancashire, United Kingdom

🇩🇪

Friedrich-Schiller-Uni. Jena, Jena, Thüringen, Germany

and more 17 locations

Staging Prostate Cancer With Hybrid C11-Choline PET/MR and mpMRI

Phase 3
Completed
Conditions
Prostate Adenocarcinoma
Interventions
Drug: C-11 choline PET tracer
Device: PET/MR scanner
First Posted Date
2018-01-19
Last Posted Date
2021-02-08
Lead Sponsor
Mayo Clinic
Target Recruit Count
19
Registration Number
NCT03404648
Locations
🇺🇸

Mayo Clinic in Arizona, Scottsdale, Arizona, United States

Gadobutrol Versus Gadopentetate Dimeglumine or Gadobenate Dimeglumine Before DCE-MRI in Diagnosing Patients With Multiple Sclerosis, Grade II-IV Glioma, or Brain Metastases

Not Applicable
Terminated
Conditions
Adult Anaplastic (Malignant) Meningioma
Adult Anaplastic Oligodendroglioma
Adult Brain Stem Glioma
Adult Choroid Plexus Neoplasm
Adult Diffuse Astrocytoma
Adult Ependymoblastoma
Adult Ependymoma
Adult Giant Cell Glioblastoma
Adult Glioblastoma
Adult Gliosarcoma
Interventions
Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging
Radiation: Gadopentetate Dimeglumine
First Posted Date
2016-11-18
Last Posted Date
2017-03-27
Lead Sponsor
University of Southern California
Target Recruit Count
14
Registration Number
NCT02967380
Locations
🇺🇸

USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States

CEST- Glucose Enhanced MRI for Metastatic Brain Tumours

Phase 2
Terminated
Conditions
Brain Neoplasms, Malignant
Metastasis
Interventions
Procedure: Magnetic resonance imaging
Drug: 50% dextrose solution
First Posted Date
2016-06-13
Last Posted Date
2019-01-28
Lead Sponsor
British Columbia Cancer Agency
Target Recruit Count
3
Registration Number
NCT02796729
Locations
🇨🇦

BC Cancer Agency- Vancouver Centre, Vancouver, British Columbia, Canada

Drug Use Investigation of Gadovist.

Completed
Conditions
Magnetic Resonance Imaging
Image Enhancement
Interventions
First Posted Date
2015-09-04
Last Posted Date
2023-11-07
Lead Sponsor
Bayer
Target Recruit Count
3357
Registration Number
NCT02540967
Locations
🇯🇵

Many Locations, Multiple Locations, Japan

Validation of the Efficacy of the Tool GIMIAS® for the Assessment of Left Atrial Fibrosis in a Group of Healthy Volunteers (RESTORE-HV)

Phase 1
Completed
Conditions
Left Atrial Fibrosis
Interventions
First Posted Date
2014-10-24
Last Posted Date
2015-08-19
Lead Sponsor
Fundacion Clinic per a la Recerca Biomédica
Target Recruit Count
9
Registration Number
NCT02274246
Locations
🇪🇸

Hospital Clinic of Barcelona, Barcelona, Spain

Contrast-enhanced MRI in Detecting Benign and Malignant Liver Lesions

Not Applicable
Active, not recruiting
Conditions
Metastatic Malignant Neoplasm in the Liver
Primary Malignant Liver Neoplasm
Hepatocellular Carcinoma
Liver and Intrahepatic Bile Duct Disorder
Interventions
Procedure: Contrast-enhanced Magnetic Resonance Imaging
First Posted Date
2014-06-05
Last Posted Date
2025-01-20
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
100
Registration Number
NCT02156739
Locations
🇺🇸

M D Anderson Cancer Center, Houston, Texas, United States

Functional Magnetic Resonance Imaging of Pancreatic Cancer: a Feasibility and Reproducibility Study

Not Applicable
Completed
Conditions
Pancreatic Cancer
Interventions
First Posted Date
2013-11-26
Last Posted Date
2017-03-20
Lead Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Target Recruit Count
23
Registration Number
NCT01995240
Locations
🇳🇱

Academic Medical Center, Amsterdam, Netherlands

The Role of the Tumor Microenvironment of Pancreatic Cancer to Predict Treatment Outcome

Not Applicable
Completed
Conditions
Pancreatic Cancer
Interventions
Radiation: Radiotherapy
Procedure: Pancreaticoduodenectomy
First Posted Date
2013-11-20
Last Posted Date
2018-06-27
Lead Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Target Recruit Count
47
Registration Number
NCT01989000
Locations
🇳🇱

Erasmus MC, Rotterdam, Zuid Holland, Netherlands

🇳🇱

Academic Medical Center, Amsterdam, Noord Holland, Netherlands

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