CLINICAL TRIALS PROFILE FOR ISOVUE-250

All Clinical Trials for Isovue-250

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.
NCT00209417 ↗	Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Computed Tomography	Terminated	Quintiles, 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-250

Condition Name

Condition Name for Isovue-250
Intervention	Trials
Diabetes Mellitus	2
Peripheral Arterial Occlusive Disease	2
Coronary Computed Tomographic Angiography	1
Non-Small Cell Lung Carcinoma	1

Condition MeSH

Condition MeSH for Isovue-250
Intervention	Trials
Kidney Diseases	3
Renal Insufficiency	3
Peripheral Arterial Disease	2
Arterial Occlusive Diseases	2

Clinical Trial Locations for Isovue-250

Trials by Country

Trials by Country for Isovue-250
Location	Trials
United States	17
Canada	1
United Kingdom	1

Trials by US State

Trials by US State for Isovue-250
Location	Trials
New Jersey	11
New York	1
Texas	1
Nebraska	1
California	1

Clinical Trial Progress for Isovue-250

Clinical Trial Phase

Clinical Trial Phase for Isovue-250
Clinical Trial Phase	Trials
Phase 4	13
Phase 3	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for Isovue-250
Clinical Trial Phase	Trials
Completed	14
Recruiting	3
Terminated	2

Clinical Trial Sponsors for Isovue-250

Sponsor Name

Sponsor Name for Isovue-250
Sponsor	Trials
Bracco Diagnostics, Inc	10
GE Healthcare	4
Quintiles, Inc.	2

Sponsor Type

Sponsor Type for Isovue-250
Sponsor	Trials
Industry	21
Other	9
NIH	1

ISOVUE-300: 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 will delve into the clinical trials, market analysis, and projections for ISOVUE-300, providing a comprehensive overview of its use, safety, and market dynamics.

Clinical Indications and Uses

ISOVUE-300 is indicated for a range of intravascular and intravenous procedures, including:

• Peripheral arteriography
• Cerebral arteriography
• Excretory urography
• Intravenous contrast enhancement in computed tomography (CT) of the head and body in adults and children
• Angiocardiography in pediatric patients[1][2][5].

Clinical Trials and Safety Profile

Clinical Trials Experience

Clinical trials involving ISOVUE-300 have been conducted to evaluate its safety and efficacy. In studies involving 2,246 adult patients, common adverse reactions (>1%) included pain, hot flashes, burning sensation, nausea, and warmth. Less common adverse reactions included cardiovascular disorders, gastrointestinal disorders, and nervous system disorders[5].

Adverse Reactions in Pediatric Patients

In a clinical trial with 76 pediatric patients undergoing angiocardiography, adverse reactions such as worsening cyanosis and worsening peripheral perfusion were reported in 2.6% of the patients[5].

Postmarketing Experience

Postmarketing surveillance has identified additional adverse reactions, including severe cutaneous adverse reactions, thromboembolic events, and thyroid dysfunction in pediatric patients[5].

Pharmacokinetics and Elimination

ISOVUE-300 is cleared primarily through renal excretion, with a half-life of approximately 2 hours. Patients with renal insufficiency are at increased risk of systemic exposure and should be managed with caution, using the lowest necessary dose and ensuring adequate hydration[1][2].

Contraindications and Warnings

ISOVUE-300 is contraindicated in patients with known hypersensitivity to the product and in those with significant impairment of both renal and hepatic functions. It is also contraindicated for intrathecal administration, which can lead to severe and potentially fatal complications[2][5].

Market Analysis

Current Market

The market for radiographic contrast agents, including ISOVUE-300, is part of the broader medical imaging market. This market is driven by the increasing demand for diagnostic imaging procedures due to an aging population and the rising incidence of chronic diseases.

Market Projections

While specific projections for ISOVUE-300 are not readily available, the overall market for contrast agents is expected to grow. The demand for advanced diagnostic imaging techniques and the expansion of healthcare services in emerging markets are key drivers of this growth.

Competitive Landscape

The market for non-ionic radiographic contrast agents is competitive, with several other products available, such as iohexol. However, ISOVUE-300 has established itself as a reliable and effective option due to its safety profile and versatility in various imaging procedures[4].

Regulatory Considerations

ISOVUE-300 is subject to stringent regulatory requirements, including those related to safety, efficacy, and manufacturing standards. Adherence to these regulations is crucial for maintaining market approval and ensuring patient safety.

Market Opportunities and Challenges

Opportunities

• Growing Demand for Diagnostic Imaging: The increasing need for diagnostic imaging due to demographic changes and the rise in chronic diseases presents a significant market opportunity.
• Advancements in Technology: Improvements in imaging technologies and the integration of contrast agents into these systems can enhance the market position of ISOVUE-300.

Challenges

• Safety Concerns: The risk of adverse reactions, particularly in patients with renal insufficiency, requires careful management and monitoring.
• Competition: The presence of other non-ionic contrast agents in the market poses a competitive challenge.

Key Takeaways

• Clinical Indications: ISOVUE-300 is widely used in various medical imaging procedures, including arteriography, urography, and CT scans.
• Safety Profile: While generally safe, ISOVUE-300 can cause adverse reactions, especially in patients with renal or hepatic impairment.
• Market Dynamics: The market for radiographic contrast agents is growing, driven by increasing demand for diagnostic imaging.
• Regulatory Compliance: Adherence to regulatory standards is essential for maintaining market approval.

FAQs

What are the common adverse reactions associated with ISOVUE-300?

Common adverse reactions include pain, hot flashes, burning sensation, nausea, and warmth. Less common reactions can include cardiovascular disorders and gastrointestinal issues[5].

Can ISOVUE-300 be used in pediatric patients?

Yes, ISOVUE-300 is indicated for use in pediatric patients for procedures such as angiocardiography and intravenous contrast enhancement in CT scans. However, special precautions are necessary, especially regarding thyroid function monitoring in young children[2][5].

What are the contraindications for ISOVUE-300?

ISOVUE-300 is contraindicated in patients with known hypersensitivity to the product, significant impairment of both renal and hepatic functions, and for intrathecal administration[2][5].

How is ISOVUE-300 eliminated from the body?

ISOVUE-300 is primarily eliminated through renal excretion, with a half-life of approximately 2 hours[1][2].

What precautions should be taken in patients with renal insufficiency?

Patients with renal insufficiency should be managed with caution, using the lowest necessary dose of ISOVUE-300 and ensuring adequate hydration to minimize the risk of acute kidney injury[2][5].

Sources

1. ISOVUE-300 Prescription & Dosage Information - MPR
2. IsovueTM Iopamidol Injection USP - Bracco
3. New survey reveals $2 trillion market opportunity for cybersecurity technology and service providers - McKinsey (Note: This source is not directly relevant to ISOVUE-300 but was included in the search results)
4. Comparative Investigation of IV Iohexol and Iopamidol - American Journal of Roentgenology
5. ISOVUE® (iopamidol) injection, for intra-arterial or intravenous use - Bracco