CLINICAL TRIALS PROFILE FOR ISOVUE-M 200

All Clinical Trials for ISOVUE-M 200

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 200

Condition Name

Condition Name for ISOVUE-M 200
Intervention	Trials
Diabetes Mellitus	2
Peripheral Arterial Occlusive Disease	2
Coronary Artery Disease	1

Condition MeSH

Condition MeSH for ISOVUE-M 200
Intervention	Trials
Kidney Diseases	3
Renal Insufficiency	3
Renal Insufficiency, Chronic	2

Clinical Trial Locations for ISOVUE-M 200

Trials by Country

Trials by Country for ISOVUE-M 200
Location	Trials
United States	17
United Kingdom	1
Canada	1

Trials by US State

Trials by US State for ISOVUE-M 200
Location	Trials
New Jersey	11
New York	1
Texas	1
Nebraska	1
California	1

Clinical Trial Progress for ISOVUE-M 200

Clinical Trial Phase

Clinical Trial Phase for ISOVUE-M 200
Clinical Trial Phase	Trials
Phase 4	13
Phase 3	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for ISOVUE-M 200
Clinical Trial Phase	Trials
Completed	14
Recruiting	3
Terminated	2

Clinical Trial Sponsors for ISOVUE-M 200

Sponsor Name

Sponsor Name for ISOVUE-M 200
Sponsor	Trials
Bracco Diagnostics, Inc	10
GE Healthcare	4
Quintiles, Inc.	2

Sponsor Type

Sponsor Type for ISOVUE-M 200
Sponsor	Trials
Industry	21
Other	9
NIH	1

ISOVUE-M 200 Market Analysis and Financial Projection

ISOVUE-M 200: Clinical Trials, Market Analysis, and Projections

Introduction

ISOVUE-M 200, a non-ionic radiographic contrast agent, is widely used in medical imaging procedures. It is formulated as an iopamidol injection and is indicated for various neuroradiological and computed tomographic (CT) procedures. Here, we will delve into the clinical trials, market analysis, and future projections for ISOVUE-M 200.

Clinical Trials and Efficacy

ISOVUE-M 200 has undergone extensive clinical trials to establish its safety and efficacy. These trials have focused on its use in intrathecal administration for myelography and CT cisternography and ventriculography.

• Myelography: Clinical studies have shown that ISOVUE-M 200 is effective for lumbar, thoracic, cervical, and total columnar myelography in adults and thoraco-lumbar myelography in children over two years old. The contrast agent provides clear visualization of the spinal canal and its contents, aiding in the diagnosis of spinal disorders[1][4].
• CT Procedures: ISOVUE-M 200 is also used for contrast enhancement in CT cisternography and ventriculography. These procedures involve the injection of the contrast agent into the spinal canal to visualize the cerebrospinal fluid spaces and ventricles of the brain. Clinical trials have demonstrated its efficacy in providing high-quality images necessary for diagnostic purposes[1][4].

Safety Profile

The safety profile of ISOVUE-M 200 has been a key focus of clinical trials.

• Adverse Reactions: Common adverse reactions include headache, gastrointestinal upset, back pain, leg pain, neck pain, and hypotension. More severe reactions, such as major motor seizures, facial neuralgia, tinnitus, and sweating, have also been reported, although these are less common[1][4].
• Contraindications: ISOVUE-M 200 is contraindicated in patients with known hypersensitivity to the product, significant local or systemic infections where bacteremia is likely, and concomitant use with corticosteroids. Repeat myelography in the event of technical failure is also contraindicated due to overdosage considerations[1][4].

Market Analysis

Current Market Status

ISOVUE-M 200 is manufactured by Bracco Diagnostics Inc. and has been approved by the FDA since 1987. It is available in various formulations, including single-dose vials for intrathecal administration[1][5].

• Market Share: Bracco Diagnostics holds a significant market share in the radiographic contrast agents segment. ISOVUE-M 200, along with other ISOVUE formulations, contributes substantially to this market presence.
• Competitive Landscape: The market for radiographic contrast agents is competitive, with other major players such as GE Healthcare and Bayer HealthCare. However, ISOVUE-M 200's established reputation and wide range of indications help it maintain a strong position.

Economic Factors

The cost of ISOVUE-M 200 can vary depending on the region and the specific formulation used.

• Cost-Effectiveness: Studies have shown that while ISOVUE-M 200 may be more expensive than some other contrast agents, its safety profile and efficacy make it a cost-effective option in the long run, particularly in reducing the need for repeat procedures and minimizing adverse reactions[3].

Regulatory Environment

FDA Approvals and Guidelines

ISOVUE-M 200 has been subject to rigorous FDA approvals and guidelines.

• Imaging Bulk Package (IBP): For intravenous use, ISOVUE is available in an Imaging Bulk Package (IBP) approved by the FDA for multi-patient use in CT suites. This packaging ensures safe and compliant use, reducing the risk of microbial contamination and maintaining chemical stability[2].
• Labeling and Warnings: The FDA has mandated specific labeling and warnings for ISOVUE-M 200, including contraindications and precautions, particularly for patients with renal impairment or those on certain medications[1][4].

Market Projections

Future Trends

The demand for radiographic contrast agents is expected to grow due to increasing diagnostic imaging procedures.

• Technological Advancements: Advances in imaging technologies, such as high-resolution CT scanners, will drive the demand for high-quality contrast agents like ISOVUE-M 200.
• Aging Population: The aging population and the increasing incidence of chronic diseases will lead to more diagnostic imaging procedures, further boosting the market for ISOVUE-M 200.

Market Growth

The global market for radiographic contrast agents is projected to grow at a significant rate over the next few years.

• Projected Revenue: The revenue from ISOVUE-M 200 and other ISOVUE formulations is expected to increase, driven by the expanding use in various medical imaging procedures and the growing need for diagnostic accuracy.
• Geographical Expansion: Bracco Diagnostics is likely to expand its market presence in emerging economies, where there is a growing demand for advanced diagnostic imaging solutions.

Key Takeaways

• Clinical Efficacy: ISOVUE-M 200 has been proven effective in various neuroradiological and CT procedures.
• Safety Profile: While generally safe, ISOVUE-M 200 has specific contraindications and potential adverse reactions that need to be considered.
• Market Position: ISOVUE-M 200 holds a strong market position due to its established reputation and wide range of indications.
• Future Growth: The market for ISOVUE-M 200 is expected to grow driven by technological advancements, an aging population, and expanding diagnostic needs.

FAQs

What is ISOVUE-M 200 used for?

ISOVUE-M 200 is used for intrathecal administration in adult neuroradiology, including myelography and contrast enhancement of CT cisternography and ventriculography. It is also used for thoraco-lumbar myelography in children over two years old[1][4].

What are the common adverse reactions of ISOVUE-M 200?

Common adverse reactions include headache, gastrointestinal upset, back pain, leg pain, neck pain, and hypotension. More severe reactions such as major motor seizures and facial neuralgia can also occur[1][4].

Is ISOVUE-M 200 contraindicated in any conditions?

Yes, ISOVUE-M 200 is contraindicated in patients with known hypersensitivity to the product, significant local or systemic infections where bacteremia is likely, and concomitant use with corticosteroids. Repeat myelography in the event of technical failure is also contraindicated[1][4].

Who manufactures ISOVUE-M 200?

ISOVUE-M 200 is manufactured by Bracco Diagnostics Inc.[1][5].

What is the expected market growth for ISOVUE-M 200?

The market for ISOVUE-M 200 is expected to grow driven by technological advancements, an aging population, and expanding diagnostic needs. The global market for radiographic contrast agents is projected to grow at a significant rate over the next few years.

Are there any generic versions of ISOVUE-M 200 available?

As of the last update, there are no generic versions of ISOVUE-M 200 available. The original formulation remains under the brand name ISOVUE-M 200 by Bracco Diagnostics Inc.[5].

Sources

1. ISOVUE-M 200 Prescription & Dosage Information - eMPR.com
2. Isovue and Isovue-M - Applied Radiology
3. IsovueTM Iopamidol Injection USP - Bracco Imaging Canada
4. ISOVUE-M 200- iopamidol injection, solution - DailyMed
5. Generic Isovue-200 Availability - Drugs.com