CLINICAL TRIALS PROFILE FOR ISOVUE-300

All Clinical Trials for ISOVUE-300

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00209417 ↗	Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Computed Tomography	Terminated	ABX CRO	Phase 4	2005-06-01	It is well known that X-ray contrast media can affect kidney function in some patients, especially when administered intra-arterially, and patients who already suffer from reduced kidney function and diabetes mellitus may be at increased risk. It is widely accepted to use low-osmolar or iso-osmolar contrast media, especially in patients at risk for contrast media-induced nephropathy. However, little is known about the intravenous use of X-ray contrast media in risk patients, such as contrast-enhanced CT examinations. The main purpose of this study is to evaluate and compare the effects on kidney function of two contrast media, the iso-osmolar iodixanol and the low-osmolar iopamidol in patients at risk of kidney damage associated with the injection of contrast media. Due to the iso-osmolar feature, it is expected less influence on renal function following administration of iodixanol. A standard hydration procedure, based on available guidelines will be given to all patients to prevent negative effects on the kidneys. Serum creatinine (SCr ) concentrations will be measured before and up to 7 days after contrast media administration to evaluate the effects on renal function.
NCT00209417 ↗	Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Computed Tomography	Terminated	ABX-CRO	Phase 4	2005-06-01	It is well known that X-ray contrast media can affect kidney function in some patients, especially when administered intra-arterially, and patients who already suffer from reduced kidney function and diabetes mellitus may be at increased risk. It is widely accepted to use low-osmolar or iso-osmolar contrast media, especially in patients at risk for contrast media-induced nephropathy. However, little is known about the intravenous use of X-ray contrast media in risk patients, such as contrast-enhanced CT examinations. The main purpose of this study is to evaluate and compare the effects on kidney function of two contrast media, the iso-osmolar iodixanol and the low-osmolar iopamidol in patients at risk of kidney damage associated with the injection of contrast media. Due to the iso-osmolar feature, it is expected less influence on renal function following administration of iodixanol. A standard hydration procedure, based on available guidelines will be given to all patients to prevent negative effects on the kidneys. Serum creatinine (SCr ) concentrations will be measured before and up to 7 days after contrast media administration to evaluate the effects on renal function.
NCT00209417 ↗	Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Computed Tomography	Terminated	Averion International Corporation	Phase 4	2005-06-01	It is well known that X-ray contrast media can affect kidney function in some patients, especially when administered intra-arterially, and patients who already suffer from reduced kidney function and diabetes mellitus may be at increased risk. It is widely accepted to use low-osmolar or iso-osmolar contrast media, especially in patients at risk for contrast media-induced nephropathy. However, little is known about the intravenous use of X-ray contrast media in risk patients, such as contrast-enhanced CT examinations. The main purpose of this study is to evaluate and compare the effects on kidney function of two contrast media, the iso-osmolar iodixanol and the low-osmolar iopamidol in patients at risk of kidney damage associated with the injection of contrast media. Due to the iso-osmolar feature, it is expected less influence on renal function following administration of iodixanol. A standard hydration procedure, based on available guidelines will be given to all patients to prevent negative effects on the kidneys. Serum creatinine (SCr ) concentrations will be measured before and up to 7 days after contrast media administration to evaluate the effects on renal function.
NCT00209417 ↗	Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Computed Tomography	Terminated	Covance	Phase 4	2005-06-01	It is well known that X-ray contrast media can affect kidney function in some patients, especially when administered intra-arterially, and patients who already suffer from reduced kidney function and diabetes mellitus may be at increased risk. It is widely accepted to use low-osmolar or iso-osmolar contrast media, especially in patients at risk for contrast media-induced nephropathy. However, little is known about the intravenous use of X-ray contrast media in risk patients, such as contrast-enhanced CT examinations. The main purpose of this study is to evaluate and compare the effects on kidney function of two contrast media, the iso-osmolar iodixanol and the low-osmolar iopamidol in patients at risk of kidney damage associated with the injection of contrast media. Due to the iso-osmolar feature, it is expected less influence on renal function following administration of iodixanol. A standard hydration procedure, based on available guidelines will be given to all patients to prevent negative effects on the kidneys. Serum creatinine (SCr ) concentrations will be measured before and up to 7 days after contrast media administration to evaluate the effects on renal function.
NCT00209417 ↗	Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Computed Tomography	Terminated	Examination Management Services Inc.	Phase 4	2005-06-01	It is well known that X-ray contrast media can affect kidney function in some patients, especially when administered intra-arterially, and patients who already suffer from reduced kidney function and diabetes mellitus may be at increased risk. It is widely accepted to use low-osmolar or iso-osmolar contrast media, especially in patients at risk for contrast media-induced nephropathy. However, little is known about the intravenous use of X-ray contrast media in risk patients, such as contrast-enhanced CT examinations. The main purpose of this study is to evaluate and compare the effects on kidney function of two contrast media, the iso-osmolar iodixanol and the low-osmolar iopamidol in patients at risk of kidney damage associated with the injection of contrast media. Due to the iso-osmolar feature, it is expected less influence on renal function following administration of iodixanol. A standard hydration procedure, based on available guidelines will be given to all patients to prevent negative effects on the kidneys. Serum creatinine (SCr ) concentrations will be measured before and up to 7 days after contrast media administration to evaluate the effects on renal function.

Clinical Trial Conditions for ISOVUE-300

Condition Name

Condition Name for ISOVUE-300
Intervention	Trials
Peripheral Arterial Occlusive Disease	2
Diabetes Mellitus	2
Drug Safety	1
Healthy	1

Condition MeSH

Condition MeSH for ISOVUE-300
Intervention	Trials
Kidney Diseases	3
Renal Insufficiency	3
Arterial Occlusive Diseases	2
Myocardial Ischemia	2

Clinical Trial Locations for ISOVUE-300

Trials by Country

+

−

Trials by Country for ISOVUE-300
Location	Trials
United States	17
United Kingdom	1
Canada	1

Trials by US State

+

−

Trials by US State for ISOVUE-300
Location	Trials
New Jersey	11
California	1
North Carolina	1
Alabama	1
New York	1

Clinical Trial Progress for ISOVUE-300

Clinical Trial Phase

Clinical Trial Phase for ISOVUE-300
Clinical Trial Phase	Trials
Phase 4	13
Phase 3	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for ISOVUE-300
Clinical Trial Phase	Trials
Completed	14
Recruiting	3
Terminated	2

Clinical Trial Sponsors for ISOVUE-300

Sponsor Name

Sponsor Name for ISOVUE-300
Sponsor	Trials
Bracco Diagnostics, Inc	10
GE Healthcare	4
i3 Statprobe	2

Sponsor Type

Sponsor Type for ISOVUE-300
Sponsor	Trials
Industry	21
Other	9
NIH	1

Isovue-300: A Comprehensive Overview of Clinical Trials, Market Analysis, and Projections

Introduction

Isovue-300, a non-ionic radiographic contrast agent, is widely used in various medical imaging procedures. This article delves into the clinical trials, market analysis, and future projections for Isovue-300, providing a thorough understanding of its role in medical imaging.

Clinical Trials and Efficacy

Indications and Usage

Isovue-300 is indicated for intrathecal administration in adult neuroradiology, including myelography, and for contrast enhancement in computed tomographic (CECT) cisternography and ventriculography. It is also used for intravascular procedures such as peripheral arteriography, cerebral arteriography, excretory urography, and intravenous contrast enhancement in computed tomography of the head or body[1][3][5].

Radiopacity and Imaging Quality

Studies have compared the radiopacity of Isovue-300 with other contrast agents. For instance, a quantitative study found that while Isovue-370 provides the highest Hounsfield unit (HU) radiopacity, Isovue-300 had lower mean HU measurements, which may result in underestimation of aneurysmal dimensions[4].

Safety and Adverse Reactions

Clinical trials and post-marketing surveillance have highlighted several potential adverse reactions associated with Isovue-300, including headache, GI upset, back pain, and hypotension. It is contraindicated in patients with known hypersensitivity to the product, significant impairment of both renal and hepatic functions, and concomitant corticosteroids[1][3][5].

Market Analysis

Market Presence and Competition

Isovue-300, manufactured by Bracco, has been approved by the FDA since 1985. The market for radiographic contrast agents is competitive, with other notable agents like Visipaque 320 and Omnipaque 300. The choice of agent often depends on the specific procedure, patient health, and the desired radiopacity[2][4].

Generic Availability

As of the latest updates, there is no generic version of Isovue-300 available in the market. The brand remains under the patent of Bracco, ensuring its market exclusivity for the foreseeable future[2].

Market Trends

The demand for radiographic contrast agents is driven by the increasing need for diagnostic imaging in healthcare. Advances in medical imaging technologies and the growing prevalence of diseases requiring imaging diagnostics are key factors driving the market growth. However, recent contrast shortages have highlighted the need for multiple suppliers and robust supply chains[4].

Market Projections

Growth Drivers

The market for radiographic contrast agents, including Isovue-300, is expected to grow due to several factors:

• Increasing Demand for Diagnostic Imaging: The rising incidence of chronic diseases and the need for early diagnosis will drive the demand for imaging procedures.
• Technological Advancements: Improvements in imaging technologies will enhance the utility and accuracy of contrast agents.
• Expanding Healthcare Infrastructure: Growing healthcare infrastructure in developing countries will increase access to diagnostic imaging services[4].

Challenges and Opportunities

Despite the growth potential, the market faces several challenges:

• Regulatory Scrutiny: Strict regulatory requirements and safety guidelines can impact the approval and use of contrast agents.
• Supply Chain Issues: Recent shortages have underscored the importance of a stable supply chain.
• Competition: The entry of new contrast agents and potential generic versions could alter market dynamics[2][4].

Patient and Clinical Considerations

Patient Safety

Isovue-300 should be administered by professionals trained in the use of radiopaque agents in appropriate facilities with emergency treatment readily available. Patients with certain conditions, such as severe cardiovascular disease, multiple sclerosis, or renal insufficiency, require special precautions and monitoring[1][3][5].

Dosage and Administration

The dosage of Isovue-300 varies based on the procedure. For example, intrathecal administration for myelography involves specific dosing guidelines to minimize risks. Patients must be fully assessed before administration, and precautions must be taken to prevent contrast media-induced nephrotoxicity[1][3].

Key Takeaways

• Isovue-300 is a widely used non-ionic radiographic contrast agent with specific indications in neuroradiology and intravascular procedures.
• Clinical Trials have established its efficacy but also highlighted potential adverse reactions and contraindications.
• Market Analysis shows a competitive market with Isovue-300 holding a significant position due to its brand exclusivity.
• Market Projections indicate growth driven by increasing demand for diagnostic imaging and technological advancements, despite challenges such as regulatory scrutiny and supply chain issues.
• Patient and Clinical Considerations emphasize the need for careful administration and monitoring to ensure patient safety.

FAQs

What are the primary indications for Isovue-300?

Isovue-300 is primarily indicated for intrathecal administration in adult neuroradiology, including myelography, and for contrast enhancement in computed tomographic (CECT) cisternography and ventriculography. It is also used for various intravascular procedures[1][3].

What are the potential adverse reactions associated with Isovue-300?

Common adverse reactions include headache, GI upset, back pain, and hypotension. Serious reactions such as hypersensitivity, acute kidney injury, and cardiovascular events can also occur[1][3][5].

Is Isovue-300 available in generic form?

As of the latest updates, there is no generic version of Isovue-300 available in the market[2].

How does Isovue-300 compare to other contrast agents in terms of radiopacity?

Isovue-300 has lower mean Hounsfield unit (HU) measurements compared to Isovue-370 but is still effective for various imaging procedures. However, it may underestimate aneurysmal dimensions compared to higher concentration agents[4].

What precautions should be taken when administering Isovue-300?

Isovue-300 should be administered by trained professionals in appropriate facilities with emergency treatment readily available. Special precautions are necessary for patients with certain medical conditions, such as severe cardiovascular disease or renal insufficiency[1][3][5].

Sources

1. eMPR: ISOVUE-M 300 Prescription & Dosage Information.
2. Drugs.com: Generic Isovue-300 Availability.
3. Bracco Imaging Canada: IsovueTM Iopamidol Injection USP.
4. Wiley Online Library: Differences in radiopacity among CT contrast agents and concentrations.
5. DailyMed: ISOVUE 300 - iopamidol injection, solution.