CLINICAL TRIALS PROFILE FOR GADODIAMIDE

All Clinical Trials for Gadodiamide

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00209391 ↗	A Safety & Efficacy Clinical Study to Evaluate the Narrowing of the Renal Arteries While Using Gadodiamide	Completed	GE Healthcare	Phase 3	2003-09-01	Magnetic Resonance Angiography (MRA) is an examination similar to Magnetic Resonance Imaging (MRI) which uses a magnetic field and a contrast medium when needed to visualize blood flow in the arterial vessels throughout the body. Gadodiamide, a contrast medium, is already approved and is used to image blood vessels by directly injecting it into the vein, but this procedure has not been formally tested to image the renal artery vessels using MR. The study is designed to determine the presence or absence of a relevant stenosis (ie greater than/equal to 50%) or occlusion in renal arteries. Intra-arterial Digital Subtraction Angiography will be used as the standard of truth.
NCT00209443 ↗	A Safety and Efficacy Clinical Study to Evaluate the Narrowing of the Aorto-iliac Arteries While Using Gadodiamide	Completed	GE Healthcare	Phase 3	2004-09-01	Magnetic Resonance Angiography (MRA) is an examination similar to Magnetic Resonance Imaging (MRI) which uses a magnetic field and a contrast medium when needed to visualize blood flow in the arterial vessels throughout the body. Gadodiamide, a contrast medium, is already approved and is used to image blood vessels by directly injecting it into the vein, but this procedure has not been formally tested to image the aorto-iliac vessels using MR. The study is designed to determine the presence or absence of a relevant stenosis (ie greater than/equal to 50%) or occlusion in aorto-iliac arteries. Intra-arterial Digital Subtraction Angiography (IADSA) will be used as the standard of truth.
NCT00908310 ↗	Post-marketing Safety Study in Patients With Moderate Renal Insufficiency Who Receive Omniscan for Contrast-enhanced Magnetic Resonance Imaging (MRI)	Completed	i3 Statprobe	Phase 4	2009-05-01	This will be an international, multi-center, post-marketing surveillance study in patients with moderate renal insufficiency who are administered gadodiamide, Omniscan, during a MRI. Omniscan will be administered intravenously at the medical discretion of the prescribing physician.
NCT00908310 ↗	Post-marketing Safety Study in Patients With Moderate Renal Insufficiency Who Receive Omniscan for Contrast-enhanced Magnetic Resonance Imaging (MRI)	Completed	GE Healthcare	Phase 4	2009-05-01	This will be an international, multi-center, post-marketing surveillance study in patients with moderate renal insufficiency who are administered gadodiamide, Omniscan, during a MRI. Omniscan will be administered intravenously at the medical discretion of the prescribing physician.
NCT02458118 ↗	Pancreatic Perfusion Using Secretin and MRI	Unknown status	University of Nottingham	Phase 1/Phase 2	2012-06-01	The purpose of this study is to assess pancreatic perfusion in patients with chronic pancreatitis at rest and after secretin stimulation and compare this to published data on pancreatic perfusion in normal subjects.
NCT03057561 ↗	Efficacy of Dotarem® (Gd-DOTA) Versus Gadovist® (Gd-DO3A-butrol) for Late Gadolinium Enhancement Cardiac Magnetic Resonance	Unknown status	Guerbet	N/A	2016-10-01	This project is designed to demonstrate equivalence of Dotarem enhanced LGE-CMR (late gadolinium enhancement cardiac MRI) with Gadoviost enhanced LGE-CMR from the standpoint of visual image quality, quantitative image quality, and association with clinical outcomes.
NCT03057561 ↗	Efficacy of Dotarem® (Gd-DOTA) Versus Gadovist® (Gd-DO3A-butrol) for Late Gadolinium Enhancement Cardiac Magnetic Resonance	Unknown status	Dipan Shah	N/A	2016-10-01	This project is designed to demonstrate equivalence of Dotarem enhanced LGE-CMR (late gadolinium enhancement cardiac MRI) with Gadoviost enhanced LGE-CMR from the standpoint of visual image quality, quantitative image quality, and association with clinical outcomes.

Clinical Trial Conditions for Gadodiamide

Condition Name

Condition Name for Gadodiamide
Intervention	Trials
Chronic Kidney Disease	1
Chronic Pancreatitis	1
Cognitive Function	1
Contrast Media	1

Condition MeSH

Condition MeSH for Gadodiamide
Intervention	Trials
Renal Insufficiency	2
Pancreatitis	1
Nephrogenic Fibrosing Dermopathy	1
Renal Insufficiency, Chronic	1

Clinical Trial Locations for Gadodiamide

Trials by Country

Trials by Country for Gadodiamide
Location	Trials
United States	5
Germany	2
United Kingdom	1
China	1

Trials by US State

Trials by US State for Gadodiamide
Location	Trials
North Carolina	1
Massachusetts	1
Illinois	1
Arizona	1
New Jersey	1

Clinical Trial Progress for Gadodiamide

Clinical Trial Phase

Clinical Trial Phase for Gadodiamide
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	2
Phase 1/Phase 2	1

Clinical Trial Status

Clinical Trial Status for Gadodiamide
Clinical Trial Phase	Trials
Completed	3
Recruiting	2
Unknown status	2

Clinical Trial Sponsors for Gadodiamide

Sponsor Name

Sponsor Name for Gadodiamide
Sponsor	Trials
GE Healthcare	3
Guerbet	2
University of Nottingham	1

Sponsor Type

Sponsor Type for Gadodiamide
Sponsor	Trials
Other	7
Industry	7

Gadodiamide and Gadolinium-Based Contrast Agents: Clinical Trials, Market Analysis, and Projections

Introduction to Gadodiamide and Gadolinium-Based Contrast Agents

Gadodiamide, a type of gadolinium-based contrast agent (GBCA), is widely used in magnetic resonance imaging (MRI) to enhance the visibility of internal body structures. Here, we will delve into the current clinical trials, market analysis, and future projections for gadodiamide and the broader category of GBCAs.

Clinical Trials: Current Status and Future Directions

RVP-001: A New Manganese-Based Alternative

While not directly focused on gadodiamide, a significant clinical trial is underway to develop a gadolinium-free alternative. The Phase 2 clinical trial for RVP-001, a manganese-based MRI contrast agent, aims to evaluate its safety, efficacy, and pharmacokinetics in patients with gadolinium-enhancing central nervous system (CNS) lesions, such as stable brain tumors or multiple sclerosis. This study compares RVP-001 imaging to GBCA imaging, highlighting the ongoing search for safer alternatives to traditional GBCAs[1].

Comparative Studies with Existing GBCAs

Another clinical trial involves comparing the efficacy and safety of gadoquatrane, a new GBCA, with already approved macrocyclic GBCAs. This Phase 3 study is designed as a multicenter, randomized, prospective double-blind, cross-over trial to evaluate the contrast enhancement in MRI for adults with known or suspected CNS pathology. This trial aims to assess whether gadoquatrane can offer comparable or superior performance to existing GBCAs[4].

Market Analysis: Current Trends and Demand

Global Market Size and Growth

The global gadolinium market, which includes GBCAs like gadodiamide, is experiencing robust growth. As of 2024, the market size stands at USD 5,883.8 million and is projected to reach USD 9,672.1 million by 2034, representing a compound annual growth rate (CAGR) of 5.2% over the forecast period. This growth is driven by the increasing demand for diagnostic imaging due to rising chronic diseases and advancements in MRI technology[2][5].

Regional Market Insights

• India: The Indian market is expected to grow at a CAGR of 7.7% until 2034, driven by investments in healthcare infrastructure and the rising prevalence of chronic diseases.
• Spain: Spain's market is forecasted to grow at a CAGR of 3.9%, supported by its strong private healthcare sector and medical tourism.
• China: China's market is projected to grow at a CAGR of 5.8%, driven by technological advancements and increasing healthcare needs[2][5].

Key Drivers of Market Growth

The demand for gadolinium-based contrast agents is fueled by several factors:

• Rising Prevalence of Chronic Diseases: Conditions like cancer, diabetes, and cardiovascular disorders necessitate early and accurate diagnostic imaging.
• Advancements in MRI Technology: Improvements in MRI technology enhance the need for high-quality contrast agents.
• Diverse Applications: Beyond medical imaging, gadolinium is used in lighting and data storage, further driving demand[2][5].

Innovations and Emerging Trends

Smart Healthcare Infrastructure

The integration of smart healthcare infrastructure is a significant emerging trend. This includes the adoption of advanced diagnostic technologies, such as MRI machines that rely heavily on GBCAs for enhanced imaging[2].

Theranostics and Data Storage

Theranostics, which combine diagnostic and therapeutic capabilities, and innovations in data storage are also driving the demand for gadolinium. These applications highlight the versatile role of gadolinium beyond traditional medical imaging[2].

Safety and Efficacy Concerns

Gadolinium Retention and Safety

One of the critical concerns with GBCAs is the retention of gadolinium in the body, which has raised safety questions. Ongoing research and the development of alternative contrast agents, like RVP-001, aim to address these concerns[1].

Clinical Trial Outcomes

Clinical trials, such as the one for frexalimab, an anti-CD40L antibody, have shown significant reductions in new gadolinium-enhancing lesions in patients with relapsing multiple sclerosis. These studies underscore the importance of GBCAs in monitoring disease activity and the need for safe and effective contrast agents[3].

Future Projections and Market Outlook

Continued Growth in Diagnostic Imaging

The demand for gadolinium-based contrast agents is expected to continue growing as diagnostic imaging becomes more prevalent. The increasing age of the global population and the rising incidence of chronic diseases will drive this demand.

Technological Advancements

Advancements in MRI technology and the development of new contrast agents will further enhance the market. Innovations in data storage and theranostics will also contribute to the growth of the gadolinium market.

Regulatory and Safety Considerations

As safety concerns around gadolinium retention continue to be addressed, regulatory bodies may impose stricter guidelines on the use of GBCAs. This could lead to increased research and development of safer alternatives, potentially impacting market dynamics.

Key Takeaways

• Clinical Trials: Ongoing trials are focused on developing safer alternatives to traditional GBCAs and comparing the efficacy of new GBCAs.
• Market Growth: The global gadolinium market is projected to grow at a CAGR of 5.2% until 2034, driven by rising chronic diseases and advancements in MRI technology.
• Regional Insights: India, Spain, and China are key markets with varying growth rates driven by local healthcare infrastructure and disease prevalence.
• Emerging Trends: Smart healthcare infrastructure, theranostics, and innovations in data storage are driving demand for gadolinium.
• Safety Concerns: Gadolinium retention and safety are critical concerns being addressed through ongoing research and the development of alternative contrast agents.

FAQs

Q: What is the primary use of gadodiamide in medical imaging?

A: Gadodiamide is used as a contrast agent in magnetic resonance imaging (MRI) to enhance the visibility of internal body structures.

Q: What are the key drivers of the global gadolinium market growth?

A: The key drivers include the rising prevalence of chronic diseases, advancements in MRI technology, and diverse applications beyond medical imaging.

Q: Are there any safety concerns associated with the use of GBCAs like gadodiamide?

A: Yes, there are concerns about gadolinium retention in the body, which has prompted research into safer alternatives.

Q: What is the projected growth rate of the Indian gadolinium market?

A: The Indian market is expected to grow at a CAGR of 7.7% until 2034.

Q: What emerging trends are influencing the demand for gadolinium?

A: Emerging trends include smart healthcare infrastructure, theranostics, and innovations in data storage.

Sources

1. Yale Medicine: A Multi-Center, Phase 2, Open Label, Ascending Dose Study to Evaluate the Safety and Efficacy of RVP-001.
2. AccessWire: Global Gadolinium Market Forecasted to Grow at 5.2% CAGR.
3. Sanofi: Positive Phase 2 data of novel investigational anti-CD40L antibody frexalimab.
4. Bayer Clinical Trials: Contrast enhancement in magnetic resonance imaging, Central Nervous System.
5. Future Market Insights: Gadolinium Market Size, Share, Trends & Forecast to 2034.

Last updated: 2025-01-03