CLINICAL TRIALS PROFILE FOR EOVIST

All Clinical Trials for Eovist

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00908596 ↗	Primovist / Eovist in Renally Impaired Patients	Completed	Bayer	Phase 4	2009-05-01	Patients with moderate to severe renal impairment scheduled for a magnetic resonance imaging (MRI) scan and injection with a contrast agent, Primovist/Eovist, will be asked to participate. The administration of contrast agents that contain gadolinium such as Primovist/Eovist might increase a potential risk to develop a rare condition called nephrogenic systemic fibrosis (NSF) in patients with renal impairment. This study is to assess the potential risk to develop NSF in patients with renal impairment after the administration of Primovist/Eovist. Patients who are enrolled in this study will receive a Primovist/Eovist enhanced MRI scan which was prescribed by the referring doctor. After the MRI scan the patient will be included in a two year follow-up period to assess if signs or symptoms suggestive of NSF have appeared.
NCT01043523 ↗	Liver MRI With Primovist/Eovist in Pediatric Subjects Who Are Suspected or Have Focal Liver Lesions.	Completed	Bayer		2009-12-01	Medical records are reviewed to obtain information about the use of a MRI diagnostic imaging agent (contrast agent) called Primovist/Eovist in children older than 2 months and less than 18 years. Data that has been recorded in the child's medical records relating to the injection of Primovist/Eovist will be collected. Information will be collected from up to 2 weeks before the child received Primovist/Eovist until 12 months after the child received Primovist/Eovist. Copy of the child's MR images that were taken right before and after the child received Primovist/Eovist and all other reports (laboratory reports, other imaging reports, etc) that are part of the child's medical records during that time period will be collected.
NCT01867424 ↗	Gadoxetate Enhanced Imaging Study to Detect Prostate Cancer	Completed	National Cancer Institute (NCI)	Phase 2	2013-05-14	Background: - Prostate cancer is the most common cancer type among men. Some prostate cancers respond to hormonal therapy. However, some cell characteristics of other prostate cancers cause it not to respond as well to these therapies. Researchers want to see if gadoxetate, a contrast agent used to help identify damaged liver tissue, can help tell these types of prostate cancer apart. It may be able to identify if a man has a type of prostate cancer for which hormone therapy may not work as well. Objectives: - To see if gadoxetate can help identify different types of prostate cancers during imaging studies. Eligibility: - Men at least 18 years of age who have prostate cancer. Participants will be having surgery to either remove the prostate or take tumor tissue samples. Design: - Participants will be screened with a physical exam and medical history. Blood samples will be collected. - Participants will have a magnetic resonance imaging (MRI) scan of the lower torso. They will receive gadoxetate during the MRI scan. - Participants who have surgery will have a sample of their tumor cells collected. Those who have a biopsy will provide cells from this biopsy for study. - Treatment will not be provided as part of this study.

Clinical Trial Conditions for Eovist

Condition Name

Condition Name for Eovist
Intervention	Trials
Liver Neoplasms	2
Contrast Media	2
Hepatocellular Carcinoma	2

Condition MeSH

Condition MeSH for Eovist
Intervention	Trials
Liver Neoplasms	4
Carcinoma, Hepatocellular	3
Carcinoma	2

Clinical Trial Locations for Eovist

Trials by Country

Trials by Country for Eovist
Location	Trials
United States	34
Germany	9
Italy	4
Korea, Republic of	4
Australia	4

Trials by US State

Trials by US State for Eovist
Location	Trials
North Carolina	4
California	4
New York	3
Massachusetts	2
Pennsylvania	2

Clinical Trial Progress for Eovist

Clinical Trial Phase

Clinical Trial Phase for Eovist
Clinical Trial Phase	Trials
Phase 4	6
Phase 3	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for Eovist
Clinical Trial Phase	Trials
Completed	8
Recruiting	4
Withdrawn	1

Clinical Trial Sponsors for Eovist

Sponsor Name

Sponsor Name for Eovist
Sponsor	Trials
National Cancer Institute (NCI)	4
Bayer	4
Seoul National University Hospital	2

Sponsor Type

Sponsor Type for Eovist
Sponsor	Trials
Other	16
Industry	6
NIH	4

Eovist: A Comprehensive Overview of Clinical Trials, Market Analysis, and Projections

Introduction

Eovist, also known as gadoxetate disodium, is a gadolinium-based contrast agent approved for use in T1-weighted magnetic resonance imaging (MRI) of the liver. It is designed to detect and characterize lesions in adults with known or suspected focal liver disease. Here, we delve into the clinical trials, market analysis, and future projections for Eovist.

Clinical Trials and Safety Profile

Approval and Indications

Eovist was first approved in Europe in 2004 and later in the U.S. in July 2008. It is indicated for intravenous use in T1-weighted MRI of the liver to detect and characterize lesions in adults[2][5].

Adverse Reactions

In clinical trials involving 1,989 patients, with 1,581 receiving the recommended dose, Eovist showed a relatively safe profile. Only 4% of subjects reported one or more reactions, which were predominantly mild to moderate in severity. The most frequent adverse reactions included nausea, headache, feeling hot, dizziness, and back pain[1].

Pediatric Use

A supplemental new drug application (NDA) was approved to extend the use of Eovist to pediatric patients. Studies in pediatric patients aged between 2 months and 18 years showed improved visualization of liver lesions without significant safety concerns. This led to the removal of the age restriction in the indication statement[5].

Mechanism and Pharmacokinetics

Dual Route of Excretion

Eovist combines features of an extracellular contrast agent and a hepatocyte-specific agent. It is administered via an intravenous bolus injection and has a dual route of excretion, with approximately 50% eliminated through the liver and 50% through the kidney[2].

Clinical Efficacy

Diagnostic Performance

Eovist significantly aids in the visualization of primary liver lesions by increasing contrast and border delineation. In pediatric studies, the administration of Eovist resulted in a change in therapy or management in 88% of subjects, highlighting its diagnostic value[5].

Impact on Patient Management

The use of Eovist often leads to changes in patient management. For instance, post-contrast MRI studies led to a change in the next course of therapy, with biopsy recommended in 53% of cases and observation in 29%[5].

Market Analysis

Global Approval and Market Presence

Eovist is approved in more than 40 countries and is marketed by Bayer HealthCare affiliates outside the U.S. as Primovist and in Japan as EOB Primovist[2].

Market Competition

The market for liver disease treatments is competitive, with various therapies and contrast agents available. However, Eovist's unique dual-action mechanism and its approval for pediatric use set it apart. The market is also influenced by emerging immunotherapies for hepatocellular carcinoma (HCC), such as Tecentriq and Avastin, although these are primarily used in different therapeutic contexts[3].

Market Projections

Sales Projections

While specific sales projections for Eovist are not readily available, the overall market for MRI contrast agents is expected to grow. The demand for advanced diagnostic tools, particularly in the context of increasing liver disease prevalence, will likely drive the sales of Eovist.

Competitive Landscape

The competitive landscape includes other gadolinium-based contrast agents, but Eovist's unique pharmacokinetics and its approval for a broad age range give it a competitive edge. However, the market will continue to evolve with the introduction of new diagnostic and therapeutic options[2][5].

Future Directions

Ongoing Research and Trials

While Eovist itself is not currently involved in new clinical trials, its use in conjunction with other imaging modalities and therapeutic agents is being explored. For example, the ACRIN legacy trials include an optional Eovist sub-trial to evaluate its additional value in imaging protocols[4].

Regulatory Considerations

The FDA has required post-marketing studies to further elucidate the risk of nephrogenic systemic fibrosis (NSF) in patients with reduced renal function. These studies have supported the safety profile of Eovist, particularly in patients with renal and hepatic immaturity[5].

Key Takeaways

• Clinical Safety and Efficacy: Eovist has a favorable safety profile with mild to moderate adverse reactions and significant diagnostic efficacy in detecting and characterizing liver lesions.
• Market Presence: Approved in over 40 countries, Eovist is a widely recognized and used contrast agent.
• Unique Mechanism: Its dual route of excretion and hepatocyte-specific action make it a valuable tool in liver imaging.
• Pediatric Use: Approved for use in pediatric patients, expanding its application range.
• Market Projections: Expected to grow with increasing demand for advanced diagnostic tools in liver disease management.

FAQs

What is Eovist used for?

Eovist is used for intravenous administration in T1-weighted MRI of the liver to detect and characterize lesions in adults with known or suspected focal liver disease[2].

What are the common adverse reactions associated with Eovist?

Common adverse reactions include nausea, headache, feeling hot, dizziness, and back pain, which are predominantly mild to moderate in severity[1].

Is Eovist approved for pediatric use?

Yes, Eovist is approved for use in pediatric patients aged between 2 months and 18 years, following studies that showed improved visualization of liver lesions without significant safety concerns[5].

How is Eovist eliminated from the body?

Eovist is eliminated through a dual route, with approximately 50% excreted through the liver and 50% through the kidney[2].

What sets Eovist apart from other contrast agents?

Eovist combines features of an extracellular contrast agent and a hepatocyte-specific agent, and its approval for pediatric use sets it apart from other gadolinium-based contrast agents[2][5].

Sources

1. Radiology Global Master V1 - Eovist-injection
2. AuntMinnie - FDA clears Bayer's Eovist MRI agent
3. Clinical Trials Arena - ESMO 2024: Tecentriq/Avastin's prospects as the first HCC adjuvant therapy
4. American College of Radiology - ACRIN Legacy Trials
5. FDA - N22-090S011 Gadoxetate Clinical PREA