Gadobutrol

Generic Name: Gadobutrol

Brand Names: Gadavist, Gadovist

Drug Type: Small Molecule

Chemical Formula: C_₁₈H_₃₁GdN_₄O_₉

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

Clinical Trials

Novel Imaging Technique to Assess Gynecologic Cancer

Phase 1

Recruiting

Conditions: Gynecologic Cancer

Interventions: Drug: Gadobutrol
Diagnostic Test: MRI

First Posted Date: 2021-05-19

Last Posted Date: 2025-03-05

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 70

Registration Number: NCT04893434

Locations: 🇺🇸
Memorial Sloan Kettering Bergen (All Protocol Activities), Montvale, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Nassau (All Protocol Activities), Uniondale, New York, United States
🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States

Effect on Body Movement and Mental Skills in Patients Who Received Gadolinium-based Contrast Media for Magnetic Resonance Examination Multiple Times Within 5 Years

Phase 4

Recruiting

Conditions: Motor Function
Cognitive Function
Contrast Media

Interventions: Procedure: Motor Tests
Procedure: Cognitive Tests
Procedure: Unenhanced-MRI of the brain
Procedure: Gadolinium Measurements
Drug: Gadoterate meglumine
Drug: Gadoxetate disodium
Drug: Gadobenate dimeglumine
Drug: Gadobutrol
Drug: Gadodiamide
Drug: Gadoteridol

First Posted Date: 2020-05-04

Last Posted Date: 2024-05-17

Lead Sponsor: Guerbet

Target Recruit Count: 2076

Registration Number: NCT04373564

Locations: 🇺🇸
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
🇺🇸
UT Southwestern Medical Center, Dallas, Texas, United States
🇧🇷
Hospital Santa Marta, Taguatinga, Distrito Federal, Brazil

and more 43 locations

Virtual Histology of the Bladder Wall for Bladder Cancer Staging

Early Phase 1

Recruiting

Conditions: Urinary Bladder Neoplasms

Interventions: Diagnostic Test: Magnetic Resonance Imaging
Drug: Gadobutrol intravesical administration (4mM)
Drug: Ferumoxytol intravesical administration (5 mM)

First Posted Date: 2020-04-30

Last Posted Date: 2024-12-12

Lead Sponsor: Jodi Maranchie

Target Recruit Count: 42

Registration Number: NCT04369560

Locations: 🇺🇸
UPMC Department of Urology, Pittsburgh, Pennsylvania, United States

Study to Find the Appropriate Dose of a New Gadolinium-based Contrast Agent (GBCA) for Adults Undergoing Magnetic Resonance Imaging (MRI) for Known or Highly Suspected Brain and/or Spinal Cord Conditions

Phase 2

Completed

Conditions: Central Nervous System Pathology

Interventions: Drug: Gadoquatrane (BAY1747846)
Drug: Gadobutrol (Gadovist/Gadavist)

First Posted Date: 2020-03-13

Last Posted Date: 2023-11-15

Lead Sponsor: Bayer

Target Recruit Count: 57

Registration Number: NCT04307186

Locations: 🇧🇬
UMHAT Sveti Georgi, Plovdiv, Bulgaria
🇧🇬
University Multiprofile Hosp. for Active Treat. Sveti Ivan, Sofia, Bulgaria
🇯🇵
National Hospital Organization Kanmon Medical Center, Shimonoseki, Yamaguchi, Japan

and more 14 locations

PET/MRI Scan for the Evaluation of Resectable Stage IA1-IB3 Cervical Cancer

Early Phase 1

Active, not recruiting

Conditions: Stage IA1 Cervical Cancer
Stage IA2 Cervical Cancer
Stage IB2 Cervical Cancer
Stage IB Cervical Cancer
Stage IB3 Cervical Cancer
Stage IA Cervical Cancer
Stage IB1 Cervical Cancer

Interventions: Other: Fludeoxyglucose F-18
Drug: Gadobutrol
Procedure: Magnetic Resonance Imaging
Procedure: Positron Emission Tomography

First Posted Date: 2020-01-07

Last Posted Date: 2025-05-16

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 25

Registration Number: NCT04219904

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

Novel MRI Techniques for the Characterization and Treatment Assessment of High Grade Brain Lesions

Not Applicable

Completed

Conditions: Brain Neoplasm
Recurrent Malignant Brain Neoplasm
Lymphoma
Metastatic Malignant Neoplasm in the Brain

Interventions: Drug: Gadobenate Dimeglumine
Drug: Gadobutrol
Procedure: Magnetic Resonance Imaging

First Posted Date: 2019-10-21

Last Posted Date: 2022-11-21

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 6

Registration Number: NCT04132843

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

Efficacy and Safety of Gadopiclenol for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)

Phase 3

Completed

Conditions: CNS Lesion
Blood Brain Barrier Defect

Interventions: Drug: gadopiclenol
Drug: Gadobutrol 1Mmol/mL Solution for Injection Vial

First Posted Date: 2019-06-24

Last Posted Date: 2021-07-02

Lead Sponsor: Guerbet

Target Recruit Count: 260

Registration Number: NCT03996447

Locations: 🇧🇪
UZ Brussel - Campus Jette, Brussel, Belgium
🇺🇸
South Carolina Clinical & Translational Research (SCTR) Institute, Charleston, South Carolina, United States
🇭🇺
Debreceni Egyetem Klinikai Kozpont, Debrecen, Hungary

and more 30 locations

Efficacy and Safety of Gadopiclenol for Body Magnetic Resonance Imaging (MRI)

Phase 3

Completed

Conditions: Lesion in Body Region

Interventions: Drug: gadopiclenol
Drug: Gadobutrol 1 MMOLE/ML Intravenous Solution

First Posted Date: 2019-06-14

Last Posted Date: 2021-11-10

Lead Sponsor: Guerbet

Target Recruit Count: 304

Registration Number: NCT03986138

Locations: 🇵🇱
Jagiellońskie Centrum Innowacji Sp. z o. o., Kraków, Poland
🇺🇸
Boston Medical Center, Boston, Massachusetts, United States
🇺🇸
UT Health San Antonio, San Antonio, Texas, United States

and more 30 locations

Dotarem Evaluation for Myocardial Perfusion CMR

Completed

Conditions: Myocardial Perfusion Imaging
Magnetic Resonance Imaging

Interventions: Drug: Gadavist 15Ml Solution for Injection

First Posted Date: 2019-05-06

Last Posted Date: 2024-11-11

Lead Sponsor: Medical University of South Carolina

Target Recruit Count: 90

Registration Number: NCT03937921

Locations: 🇺🇸
Medical University of South Carolina, Charleston, South Carolina, United States

Gadolinium-Based-Contrast-Agents (GBCA) Enhancement During MR Urography

Completed

Conditions: Magnetic Resonance Imaging Contrast Agents

Interventions: Drug: Gadovist
Drug: Magnevist
Drug: Dotarem

First Posted Date: 2019-04-10

Last Posted Date: 2019-04-10

Lead Sponsor: Vanderbilt University Medical Center

Target Recruit Count: 500

Registration Number: NCT03910114

Locations: 🇺🇸
Vanderbilt Childeen's Hospital, Nashville, Tennessee, United States
🇺🇸
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States

Drug Development Updates

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