CLINICAL TRIALS PROFILE FOR GADAVIST

All Clinical Trials for Gadavist

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.
NCT00468819 ↗	A Study of Magnetic Resonance Imaging (MRI) With Gadavist in Children	Completed	Bayer	Phase 1	2007-05-01	In this clinical study a contrast agent for magnetic resonance imaging (MRI), which has already been approved for application in adults, will be investigated in children and adolescents. MRI is a modern and safe examination method without delivering radiation burden using magnetic fields to produce cross-sectional images of the human body. A special computer program then puts these images together and creates a two or three-dimensional image of the inner organs thus facilitating the detection and evaluation of pathological changes. In contrast-enhanced MRI a contrast agent is injected into a peripheral vein before the examination which results in a stronger contrast in the examined area. Therefore, pathological changes can be more easily detected and evaluated compared to non-enhanced MRI. The company Bayer HealthCare Pharmaceuticals has developed a contrast agent for MRI called Gadavist 1.0 which was first approved in 1998 in Switzerland for MRI of brain and spine. Since 2003 Gadavist can also be used in magnetic resonance angiography (MRA) in adults, i.e. in the MRI examination of the blood vessels and since 2006 in MRI of liver and kidney disease. Gadavist was examined in more than 2,900 adults within the framework of clinical studies during development and has been used after its marketing authorization in meanwhile more than 600,000 patients. Yet, clinical studies investigating Gadavist have been only conducted with adults so far. Diseases requiring MRI examinations, however, often occur in children, too. Therefore, many contrast agents are already used on a regular basis in MRI examinations of children, some of these contrast agents being authorized already. Within the framework of this study the pharmacokinetic characteristics of Gadavist in children or adolescents will be investigated, i.e. how the contrast agent is distributed and behaves in the body. In addition, safety and tolerability will be evaluated in order to demonstrate that Gadavist 1.0 is a safe and well tolerated contrast agent also for children and adolescents. Furthermore, the study aims to obtain the dosage recommendation of 0.1 ml per kilogram body weight also for this population group.
NCT00623467 ↗	Safety and Efficacy of Gadobutrol 1.0 Molar ( Gadavist ) in Patients for Central Nervous System (CNS) Imaging	Completed	Bayer	Phase 3	2007-12-01	This is a study involving the use of Magnetic Resonance Imaging (MRI) contrast agents called Gadavist. The purpose of this study is to look at the safety (what are the side effects) and efficacy (how well does it work) of Gadavist when used for taking images of the brain and spine. The results of the MRI will be compared to the results of images taken without Gadavist.

Clinical Trial Conditions for Gadavist

Condition Name

Condition Name for Gadavist
Intervention	Trials
Central Nervous System Diseases	3
Magnetic Resonance Imaging	2
Coronary Artery Disease	2
Multiple Sclerosis	2

Condition MeSH

Condition MeSH for Gadavist
Intervention	Trials
Brain Neoplasms	4
Nervous System Diseases	3
Myocardial Ischemia	3
Central Nervous System Diseases	3

Clinical Trial Locations for Gadavist

Trials by Country

Trials by Country for Gadavist
Location	Trials
United States	102
Germany	35
Colombia	10
Japan	10
Korea, Republic of	9

Trials by US State

Trials by US State for Gadavist
Location	Trials
California	9
Texas	7
Pennsylvania	7
Missouri	6
Massachusetts	6

Clinical Trial Progress for Gadavist

Clinical Trial Phase

Clinical Trial Phase for Gadavist
Clinical Trial Phase	Trials
Phase 4	5
Phase 3	7
Phase 2	5

Clinical Trial Status

Clinical Trial Status for Gadavist
Clinical Trial Phase	Trials
Completed	14
Recruiting	10
Not yet recruiting	2

Clinical Trial Sponsors for Gadavist

Sponsor Name

Sponsor Name for Gadavist
Sponsor	Trials
Bayer	10
National Cancer Institute (NCI)	5
M.D. Anderson Cancer Center	3

Sponsor Type

Sponsor Type for Gadavist
Sponsor	Trials
Other	20
Industry	15
NIH	6

Gadavist (Gadobutrol): Clinical Trials Update, Market Analysis, and Projections

Introduction

Gadavist, also known as gadobutrol, is a macrocyclic gadolinium-based contrast agent (GBCA) widely used in magnetic resonance imaging (MRI) procedures. Here, we will delve into recent clinical trials, market analysis, and future projections for this crucial diagnostic tool.

Clinical Trials Update

Recent Clinical Trials

A significant clinical trial involving Gadavist is the multicenter, single-blind, adaptive dose-finding study (EudraCT Number 2019-001560-30). This study aimed to identify a dose of gadoquatrane (another GBCA) that has a diagnostic preference rate similar to that of Gadavist at 5 minutes post-injection. The trial was conducted at 17 study centers in four countries between November 2020 and September 2022. Participants received both Gadavist and gadoquatrane in a controlled, single-blind manner. The trial concluded on December 14, 2022, without any premature termination, and the results were published on December 25, 2023[1].

Efficacy of Reduced-Dose Gadobutrol

Another notable study, the LEADER-75 trial, investigated the efficacy of a 25% reduced dose of Gadavist compared to the standard dose of gadoterate for contrast-enhanced MRI of the central nervous system (CNS). The trial found that the reduced dose of Gadavist was noninferior to the standard dose of gadoterate in terms of lesion enhancement, border delineation, and internal morphology. This study supports the use of reduced-dose Gadavist, particularly for patients undergoing multiple contrast-enhanced examinations[4].

Safety Profile and Regulatory Considerations

Nephrogenic Systemic Fibrosis (NSF) Risk

Gadavist is classified as a lower-risk GBCA for NSF, a serious condition associated with gadolinium exposure in patients with renal impairment. The FDA has recommended that the labeling carry a class box warning about NSF but without contraindication for renally impaired patients[3].

Risk of Overdose

The higher concentration formulation of Gadavist (1.0 M) poses a risk of overdose if not administered correctly. However, the benefits of this formulation, including faster infusion and better image quality, outweigh the manageable risk of overdose. Appropriate measures to minimize this risk have been included in the labeling[3].

Market Analysis

Market Size and Growth

The U.S. gadolinium-based contrast media market, which includes Gadavist, was valued at USD 527.9 million in 2019 and is expected to grow at a compound annual growth rate (CAGR) of 4.7% from 2020 to 2027. This growth is driven by the increasing prevalence of chronic diseases and technological advancements[2].

Key Players and Market Share

Bayer AG, the manufacturer of Gadavist, is one of the major players in the contrast agents market. Along with GE Healthcare and Guerbet, these companies dominate the market due to their top-selling products and strategic expansions. Bayer's Gadavist holds a significant share in the MRI contrast agents market[5].

Geographical Dominance

North America, particularly the U.S., is a dominant region in the global contrast agents market due to good quality healthcare and favorable reimbursement facilities. This region continues to drive the demand for diagnostic and interventional radiology procedures, including those using Gadavist[5].

Market Projections

Growth Drivers

The market for Gadavist and other contrast agents is expected to grow due to several factors:

• Increasing Prevalence of Chronic Diseases: By 2025, an estimated 49% of the U.S. population will suffer from chronic diseases, driving the demand for diagnostic imaging procedures[2].
• Technological Advancements: Improvements in medical imaging technologies and the expansion of indications for contrast media are key drivers of market growth[5].
• Strategic Moves by Key Players: Mergers, acquisitions, and indication extensions by major players like Bayer AG will continue to enhance their market position[2].

Challenges

Despite the growth potential, the market faces challenges such as:

• Side Effects and Safety Concerns: Side effects associated with contrast agents, including the risk of NSF and anaphylaxis, are factors that could hamper market growth[5].
• Stringent Regulations: Regulatory requirements and safety warnings can impact the adoption rate of new and existing contrast agents[5].

Clinical Impact and Future Considerations

Diagnostic Efficacy

The clinical trials have consistently shown that Gadavist, even at reduced doses, maintains high diagnostic efficacy. This is crucial for patients undergoing multiple MRI procedures, as it reduces the overall gadolinium exposure while maintaining image quality[4].

Patient Safety

The emphasis on patient safety, particularly in terms of NSF risk and overdose prevention, will continue to be a focal point. Ongoing pharmacovigilance and updates to labeling will help in managing these risks effectively[3].

Key Takeaways

• Clinical Trials: Recent trials have focused on dose optimization and comparative efficacy of Gadavist with other GBCAs.
• Market Growth: The U.S. gadolinium-based contrast media market is expected to grow at a CAGR of 4.7% from 2020 to 2027.
• Safety Profile: Gadavist is considered a lower-risk GBCA for NSF, but overdose risks need careful management.
• Market Dominance: Bayer AG, along with other major players, dominates the market due to strategic expansions and top-selling products.
• Future Considerations: Technological advancements, indication expansions, and patient safety measures will drive the market forward.

FAQs

What is Gadavist used for?

Gadavist (gadobutrol) is a macrocyclic gadolinium-based contrast agent used in magnetic resonance imaging (MRI) procedures, particularly for imaging the central nervous system (CNS) and other body parts.

What are the key findings of the LEADER-75 trial?

The LEADER-75 trial found that a 25% reduced dose of Gadavist is noninferior to the standard dose of gadoterate for contrast-enhanced MRI of the CNS in terms of diagnostic efficacy.

What are the safety concerns associated with Gadavist?

Gadavist carries a risk of nephrogenic systemic fibrosis (NSF) in patients with renal impairment, although it is classified as a lower-risk GBCA. There is also a risk of overdose due to its higher concentration formulation.

How is the market for Gadavist expected to grow?

The U.S. gadolinium-based contrast media market, which includes Gadavist, is expected to grow at a CAGR of 4.7% from 2020 to 2027, driven by increasing chronic diseases and technological advancements.

Who are the major players in the contrast agents market?

Bayer AG, GE Healthcare, and Guerbet are the major players in the contrast agents market, with Bayer's Gadavist being a significant product in the MRI contrast agents segment.

Sources

1. EU Clinical Trials Register: EudraCT Number 2019-001560-30.
2. Grand View Research: U.S. Gadolinium-based Contrast Media Market Report, 2027.
3. FDA: 201277Orig1s000 - accessdata.fda.gov.
4. PubMed: Clinical Efficacy of Reduced-Dose Gadobutrol Versus Standard-Dose Gadoterate.
5. GlobeNewswire: Global Contrast Agents Market Report 2019-2025.