MedPath

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

The Multicenter Stress Cardiac Magnetic Resonance Quantitative Perfusion Imaging in the United States Study

Not Applicable
Not yet recruiting
Conditions
Ischemic Heart Disease (IHD)
Cardiac Magnetic Resonance Imaging
Myocardial Blood Flow
Interventions
Diagnostic Test: Qualitative Myocardial Blood Flow Evaluation
Diagnostic Test: Quantitative Myocardial Blood Flow Evaluation
Drug: Vasodilator
Diagnostic Test: Blood draw for the laboratory assessment
First Posted Date
2025-03-03
Last Posted Date
2025-03-03
Lead Sponsor
Brigham and Women's Hospital
Target Recruit Count
1000
Registration Number
NCT06854458
Locations
🇺🇸

Brigham and Women's Hospital, Boston, Massachusetts, United States

Gadopiclenol vs. Gadobutrol for Dynamic Contrast-Enhanced Pituitary MRI (Magnetic Resonance Imaging)

Phase 4
Recruiting
Conditions
Contrast Enhanced Images vs. Non-contrast Images
Gadopiclinol Enhanced Images vs. Gadobutrol Enhanced Images
Interventions
First Posted Date
2025-02-26
Last Posted Date
2025-04-15
Lead Sponsor
UConn Health
Target Recruit Count
10
Registration Number
NCT06846853
Locations
🇺🇸

University of Connecticut Health Center, Farmington, Connecticut, United States

A Study for Adults Undergoing Magnetic Resonance Imaging (MRI) for Known or Highly Suspected Brain and/or Spinal Cord Conditions

Phase 2
Not yet recruiting
Conditions
For Contrast-enhanced Magnetic Resonance Imaging (MRI) of Central Nervous System (CNS) Lesions
Interventions
First Posted Date
2024-12-12
Last Posted Date
2024-12-12
Lead Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Target Recruit Count
78
Registration Number
NCT06731829
Locations
🇨🇳

People's Hospital, Peking University, Peking, Beijing, China

MR Image Synthesis With Low Gadobutrol Dose and AI

Phase 1
Conditions
Enhancing Brain Lesions
Interventions
Device: SubtleGAD
First Posted Date
2024-01-25
Last Posted Date
2024-07-03
Lead Sponsor
Subtle Medical
Target Recruit Count
60
Registration Number
NCT06224543
Locations
🇺🇸

Central Illinois Radiological Associates; OSF St. Francis Hospital Peoria, Peoria, Illinois, United States

🇺🇸

UMass Chan Medical School, Worcester, Massachusetts, United States

🇺🇸

The Pennsylvania State University, State College, Pennsylvania, United States

and more 2 locations

A Study to Compare How Well Gadoquatrane Works and Its Safety With an Already Available Contrast Agent for MRI in People With Any Known or Suspected Problems of the Body (Except Brain or Spinal Cord-related Problems)

Phase 3
Completed
Conditions
Contrast Enhancement in Magnetic Resonance Imaging
Non-central Nervous System Pathology
Interventions
First Posted Date
2023-06-23
Last Posted Date
2025-05-08
Lead Sponsor
Bayer
Target Recruit Count
404
Registration Number
NCT05915728
Locations
🇨🇿

Fakultni nemocnice Plzen - Lochotin, Plzen, Czechia

🇦🇷

Sanatorio Allende | Departamento de Investigación Clínica, Córdoba, Argentina

🇫🇷

Hôpital Bichat Claude Bernard - Service de radiologie, Paris, France

and more 82 locations

A Study to Compare How Well Gadoquatrane Works and Its Safety With an Already Available Contrast Agent for MRI in People With Known or Suspected Brain or Spinal Cord-related Problems

Phase 3
Completed
Conditions
Central Nervous System Pathology
Contrast Enhancement in Magnetic Resonance Imaging
Interventions
First Posted Date
2023-06-23
Last Posted Date
2025-05-08
Lead Sponsor
Bayer
Target Recruit Count
303
Registration Number
NCT05915702
Locations
🇨🇿

Fakultni nemocnice Plzen - Lochotin, Plzen, Czechia

🇭🇺

Szent Damjan Gorogkatolikus Korhaz, Kisvarda, Hungary

🇭🇺

Idegsebeszeti Klinika, Pecs, Hungary

and more 75 locations

Phenotyping Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) by Intravesical Contrast Enhanced - Magnetic Resonance Imaging (ICE-MRI) Bladder Permeability Assay

Early Phase 1
Recruiting
Conditions
IC - Interstitial Cystitis
Interventions
First Posted Date
2023-04-13
Last Posted Date
2025-03-18
Lead Sponsor
Christopher J Chermansky, MD
Target Recruit Count
8
Registration Number
NCT05811377
Locations
🇺🇸

UPMC Magee Women's Hospital, Pittsburgh, Pennsylvania, United States

A Study Called GUS to Understand How Much of the Contrast Agent Gadavist is Used and How Much is Wasted in Two Different Containers (Single-dose Vials and Imaging Bulk Packages ) in a Real-world Setting

Completed
Conditions
Contrast Enhancement in Magnetic Resonance Imaging
Interventions
First Posted Date
2022-04-28
Last Posted Date
2024-04-01
Lead Sponsor
Bayer
Target Recruit Count
1602
Registration Number
NCT05350189
Locations
🇺🇸

Allegheny General Hospital, Pittsburgh, Pennsylvania, United States

🇺🇸

Western Pennsylvania Hospital, Pittsburgh, Pennsylvania, United States

Investigational MRI Clinical Software and Hardware

Phase 4
Recruiting
Conditions
Image, Body
Interventions
First Posted Date
2022-01-31
Last Posted Date
2024-12-16
Lead Sponsor
Northwestern University
Target Recruit Count
2000
Registration Number
NCT05215132
Locations
🇺🇸

Northwestern University- Feinberg School of Medicine, Chicago, Illinois, United States

PSMA-Targeted 18F-DCFPyL PET/MRI for the Detection of Prostate Cancer

Phase 2
Not yet recruiting
Conditions
Prostate Carcinoma
Interventions
Drug: Fluorine F 18 DCFPyL
Procedure: Magnetic Resonance Imaging
Procedure: Multiparametric Magnetic Resonance Imaging
Procedure: Positron Emission Tomography
Procedure: Transrectal Ultrasonography Guided Biopsy
First Posted Date
2021-06-02
Last Posted Date
2022-08-03
Lead Sponsor
Northwestern University
Target Recruit Count
106
Registration Number
NCT04910425
Locations
🇺🇸

Northwestern University, Chicago, Illinois, United States

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