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Last Updated: June 26, 2022

CLINICAL TRIALS PROFILE FOR GADOBUTROL


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505(b)(2) Clinical Trials for Gadobutrol

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Dosage NCT03602339 ↗ Comparison of Gadovist 75% Standard Dose to Dotarem at Full Standard Dose Completed Bayer Phase 4 2018-11-14 The study was conducted to gain knowledge about a new dose of a diagnostic drug that is used for contrast-enhanced Magnetic Resonance Imaging (MRI) of the human central nervous system (CNS). MRI can visualize the anatomy of the body and is used to detect medical conditions. Diagnostic drugs like gadobutrol and gadoterate contain an element called gadolinium that is applied to improve the analysability of MRI-images. The purpose of this study was to examine if contrast-enhanced MRI using a reduced dose of the gadolinium-based contrast agent gadobutrol delivers images of similar quality to those obtained when a full dose of the gadolinium-based contrast agent gadoterate was used.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Gadobutrol

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00375830 ↗ Combined 18F-NaF/18F-FDG PET/MRI for Detection of Skeletal Metastases Completed Stanford University Phase 2 2006-01-01 This clinical trial studies the use of sodium fluorine-18 (18F-NaF) plus fluorine-18 (18F) fluorodeoxyglucose (FDG) positron emission tomography (PET)/ whole body magnetic resonance imaging (WBMRI) to detect skeletal metastases in patients with stage III-IV breast cancer or stage II-IV prostate cancer.
NCT00395460 ↗ Efficacy and Safety Study to Evaluate Gadavist (Gadobutrol) as Contrast Agent in Magnetic Resonance Imaging (MRI) of Brain or Spine Diseases in Chinese Patients Completed Bayer Phase 3 2006-09-01 The purpose of this study is to determine if the contrast agent is effective and safe in the Magnetic Resonance Imaging (MRI) of brain or spine diseases in patients of Chinese origin.
NCT00395733 ↗ Efficacy and Safety Study to Evaluate Gadavist (Gadobutrol) as Contrast Agent in Magnetic Resonance Imaging (MRI) of Vascular Diseases in Chinese Patients Completed Bayer Phase 3 2006-10-01 The purpose of this study is to determine if the contrast agent is effective and safe in the Magnetic Resonance Imaging (MRI) of vascular diseases in patients of Chinese origin.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Gadobutrol

Condition Name

Condition Name for Gadobutrol
Intervention Trials
Magnetic Resonance Imaging 5
Coronary Artery Disease 3
Central Nervous System Diseases 3
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Condition MeSH

Condition MeSH for Gadobutrol
Intervention Trials
Brain Neoplasms 4
Nervous System Diseases 3
Myocardial Ischemia 3
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Clinical Trial Locations for Gadobutrol

Trials by Country

Trials by Country for Gadobutrol
Location Trials
United States 154
Germany 62
Japan 37
Italy 20
Colombia 16
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Trials by US State

Trials by US State for Gadobutrol
Location Trials
Illinois 13
California 12
Massachusetts 11
Texas 11
Pennsylvania 9
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Clinical Trial Progress for Gadobutrol

Clinical Trial Phase

Clinical Trial Phase for Gadobutrol
Clinical Trial Phase Trials
Phase 4 6
Phase 3 16
Phase 2 5
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Clinical Trial Status

Clinical Trial Status for Gadobutrol
Clinical Trial Phase Trials
Completed 27
Recruiting 8
Terminated 2
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Clinical Trial Sponsors for Gadobutrol

Sponsor Name

Sponsor Name for Gadobutrol
Sponsor Trials
Bayer 19
National Cancer Institute (NCI) 6
Guerbet 6
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Sponsor Type

Sponsor Type for Gadobutrol
Sponsor Trials
Industry 26
Other 22
NIH 6
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