CLINICAL TRIALS PROFILE FOR ISOVUE-M 300

All Clinical Trials for Isovue-m 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.

Clinical Trial Conditions for Isovue-m 300

Condition Name

Condition Name for Isovue-m 300
Intervention	Trials
Diabetes Mellitus	2
Peripheral Arterial Occlusive Disease	2
Contrast Induced Nephropathy	1

Condition MeSH

Condition MeSH for Isovue-m 300
Intervention	Trials
Kidney Diseases	3
Renal Insufficiency	3
Coronary Artery Disease	2

Clinical Trial Locations for Isovue-m 300

Trials by Country

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

Trials by US State

Trials by US State for Isovue-m 300
Location	Trials
New Jersey	11
New York	1
Texas	1
Nebraska	1
California	1

Clinical Trial Progress for Isovue-m 300

Clinical Trial Phase

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

Clinical Trial Status

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

Clinical Trial Sponsors for Isovue-m 300

Sponsor Name

Sponsor Name for Isovue-m 300
Sponsor	Trials
Bracco Diagnostics, Inc	10
GE Healthcare	4
Duke University	2

Sponsor Type

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

Isovue-M 300: Clinical Trials, Market Analysis, and Projections

Introduction to Isovue-M 300

Isovue-M 300, a non-ionic radiopaque contrast agent, contains the active ingredient iopamidol. It is used for various diagnostic procedures, including myelography, computed tomographic (CT) cisternography, and ventriculography, as well as for contrast enhancement in CT scans of the head, body, and blood vessels[2][4].

Clinical Trials and Efficacy

Overview of Clinical Studies

Clinical trials for Isovue-M 300 have focused on its safety and efficacy in various radiologic procedures. These studies have demonstrated that Isovue-M 300 is effective in providing clear radiographic visualization of internal structures, particularly in the nervous system and blood vessels.

Safety Profile

In clinical studies, Isovue-M 300 has shown a generally favorable safety profile, although it is not devoid of risks. Common adverse reactions include headache, GI upset, back pain, and hypotension. More severe reactions, such as allergic reactions and severe skin reactions, can also occur, albeit less frequently[1][4].

Specific Findings

• Intravascular Use: Studies have shown that intravascular injection of Isovue-M 300 results in significant transient changes in vital signs and hemodynamic parameters. However, these changes are typically short-lived and manageable[3].
• Intrathecal Administration: For myelography and other intrathecal procedures, Isovue-M 300 has been found to be safe and effective when used appropriately, with precautions taken to avoid complications such as increased intracranial pressure and seizures[1][2].

Market Analysis

Market Position

Isovue-M 300 is a prescription-only medication manufactured by Bracco, a well-established company in the diagnostic imaging sector. The drug competes in the market for non-ionic radiopaque contrast agents, which is a niche but critical segment in the broader diagnostic imaging market.

Market Trends

The demand for contrast agents like Isovue-M 300 is driven by the increasing need for diagnostic imaging procedures, particularly in the fields of neurology, cardiology, and oncology. Advances in imaging technologies and the growing prevalence of chronic diseases are expected to sustain this demand.

Competitive Landscape

The market for non-ionic contrast agents is competitive, with other products such as Omnipaque (iohexol) and Visipaque (iodixanol) also available. However, Isovue-M 300 has a strong reputation for its safety profile and efficacy, which helps it maintain a significant market share[5].

Market Projections

Growth Drivers

• Increasing Diagnostic Procedures: The rising incidence of diseases that require advanced diagnostic imaging, such as stroke, cancer, and cardiovascular diseases, is expected to drive the demand for Isovue-M 300.
• Technological Advancements: Improvements in CT and MRI technologies will continue to enhance the utility of contrast agents like Isovue-M 300.
• Aging Population: The growing elderly population, which is more prone to chronic diseases, will also contribute to increased demand.

Market Size and Forecast

The global market for contrast agents is projected to grow at a moderate rate over the next few years. Specifically, the non-ionic contrast agent segment, where Isovue-M 300 is positioned, is expected to see significant growth due to its safety and efficacy profile.

Regional Analysis

The market for Isovue-M 300 is expected to be strong in regions with well-developed healthcare systems, such as North America and Europe. Emerging markets in Asia and Latin America are also anticipated to contribute to the growth, driven by increasing healthcare spending and improving diagnostic capabilities.

Regulatory Environment

Approvals and Compliance

Isovue-M 300 has received regulatory approvals in various countries for its indicated uses. It is essential for the manufacturer to comply with ongoing regulatory requirements and to monitor any changes in guidelines or safety standards that may affect the drug's market position.

Safety Monitoring

Post-marketing surveillance is crucial to ensure the continued safety of Isovue-M 300. Manufacturers must maintain robust pharmacovigilance programs to monitor and report any adverse reactions or safety concerns.

Key Takeaways

• Efficacy and Safety: Isovue-M 300 has been proven effective and relatively safe in clinical trials for various diagnostic procedures.
• Market Position: It holds a significant position in the market for non-ionic radiopaque contrast agents.
• Growth Drivers: Increasing diagnostic procedures, technological advancements, and an aging population are expected to drive market growth.
• Regulatory Compliance: Ongoing compliance with regulatory requirements and safety monitoring are critical for maintaining market approval and trust.

FAQs

What is Isovue-M 300 used for?

Isovue-M 300 is used as a radiopaque contrast agent to help diagnose disorders of the heart, brain, blood vessels, and nervous system through various radiologic procedures such as myelography and CT scans[2][4].

What are the common side effects of Isovue-M 300?

Common side effects include headache, GI upset, back pain, and hypotension. More severe reactions like allergic reactions and severe skin reactions can also occur[1][4].

How is Isovue-M 300 administered?

Isovue-M 300 is administered as an infusion into a vein or artery by a healthcare provider. It is essential to follow specific guidelines to prevent side effects and ensure proper hydration before and after the procedure[4].

What are the contraindications for Isovue-M 300?

Contraindications include known hypersensitivity to the product, significant impairment of both renal and hepatic functions, and concomitant use with corticosteroids. Repeat myelography in the event of technical failure is also contraindicated[1][3].

How does Isovue-M 300 affect kidney function?

Isovue-M 300 can cause dehydration and affect kidney function, particularly in patients with pre-existing renal impairment. It is crucial to monitor kidney function and ensure adequate hydration before and after the procedure[3][4].

Can Isovue-M 300 interfere with other medical tests?

Yes, Isovue-M 300 can interfere with certain medical tests for up to 16 days after administration. Patients should inform their doctors about recent use of this medication[4].

Last updated: 2025-01-07