CLINICAL TRIALS PROFILE FOR IOPAMIDOL-250

All Clinical Trials for Iopamidol-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.

Clinical Trial Conditions for Iopamidol-250

Condition Name

Condition Name for Iopamidol-250
Intervention	Trials
Coronary Artery Stenosis	3
Diabetes Mellitus	2
Coronary Artery Disease	2
Breast Cancer	1

Condition MeSH

Condition MeSH for Iopamidol-250
Intervention	Trials
Renal Insufficiency	6
Renal Insufficiency, Chronic	3
Diabetes Mellitus	3
Kidney Diseases	3

Clinical Trial Locations for Iopamidol-250

Trials by Country

Trials by Country for Iopamidol-250
Location	Trials
United States	20
Italy	2
China	2
Canada	2
Singapore	1

Trials by US State

Trials by US State for Iopamidol-250
Location	Trials
New Jersey	10
California	2
North Carolina	2
Illinois	2
Texas	1

Clinical Trial Progress for Iopamidol-250

Clinical Trial Phase

Clinical Trial Phase for Iopamidol-250
Clinical Trial Phase	Trials
Phase 4	16
Phase 2/Phase 3	1
Phase 2	2

Clinical Trial Status

Clinical Trial Status for Iopamidol-250
Clinical Trial Phase	Trials
Completed	15
Recruiting	5
Terminated	5

Clinical Trial Sponsors for Iopamidol-250

Sponsor Name

Sponsor Name for Iopamidol-250
Sponsor	Trials
Bracco Diagnostics, Inc	8
GE Healthcare	6
i3 Statprobe	3

Sponsor Type

Sponsor Type for Iopamidol-250
Sponsor	Trials
Industry	27
Other	22
NIH	2

Iopamidol-250: Clinical Trials, Market Analysis, and Projections

Introduction to Iopamidol-250

Iopamidol-250, marketed under the brand name ISOVUE-250, is a non-ionic iodinated contrast agent used in various medical imaging procedures. It is designed to enhance the quality of images in computed tomography (CT) scans, angiography, and other diagnostic imaging techniques.

Mechanism of Action

Iopamidol-250 works by enhancing the radiographic efficiency of computed tomographic imaging. The iodine content in the administered dose directly influences the degree of tissue density visualization. Upon rapid injection, peak iodine blood levels are achieved immediately, allowing for clear visualization of internal structures. In the case of CT head imaging, iopamidol does not accumulate in normal brain tissue due to the blood-brain barrier, while in non-neural tissues, it diffuses rapidly from the vascular into the extravascular space[1][5].

Clinical Indications

ISOVUE-250 is indicated for a wide range of intravascular procedures, including:

• Angiography throughout the cardiovascular system, including cerebral and peripheral arteriography, coronary arteriography, and ventriculography.
• Pediatric angiocardiography.
• Selective visceral arteriography and aortography.
• Peripheral venography (phlebography).
• Adult and pediatric intravenous excretory urography.
• Intravenous contrast enhancement of computed tomographic (CECT) head and body imaging in adults and children[1][3].

Clinical Trials and Studies

Recent studies have compared the efficacy and safety of iopamidol with other contrast agents. For instance, a comparative analysis between iopamidol 250 and ioversol 320 in transcatheter arterial chemoembolization (TACE) for hepatocellular carcinoma (HCC) showed no significant differences in image quality or adverse events. This study indicated that iopamidol 250 can be used in hepatic angiography without compromising image quality or increasing adverse events compared to ioversol 320[4].

Pharmacokinetics and Safety Profile

Iopamidol is characterized by its rapid distribution and elimination. It follows an open two-compartment model with a rapid alpha-phase for drug distribution and a slow beta-phase for drug elimination. The elimination half-life is approximately two hours and is not dose-dependent. Iopamidol is excreted unchanged mainly by glomerular filtration, with minimal metabolism or biotransformation. Clinical studies have shown that intravascular administration of ISOVUE can result in transient changes in vital signs and hemodynamic parameters, but these are generally well-tolerated[3][5].

Market Analysis

The iopamidol injection market is poised for significant growth from 2022 to 2028, driven by several key factors:

• Increasing Demand for Advanced Imaging Techniques: The rising need for diagnostic imaging procedures, particularly in diagnostics and therapeutic settings, is a major driver.
• Advancements in Healthcare Infrastructure: Improvements in healthcare infrastructure, especially in emerging markets, are enhancing the availability and accessibility of advanced imaging technologies.
• Rising Incidences of Chronic Diseases: The growing prevalence of chronic diseases and the increasing geriatric population are leading to a higher demand for imaging procedures.
• Technological Innovations: The development of more efficient and safer contrast agents, along with advancements in imaging systems, is positively influencing market dynamics[2].

Market Projections

The iopamidol injection market is expected to grow at a compound annual growth rate (CAGR) of 7.4% during the forecast period from 2022 to 2028. This growth is attributed to the increasing focus on improving diagnostic accuracy and patient outcomes. Here are some key projections:

• Geographical Dominance: North America is anticipated to dominate the market, capturing approximately 40% of the market share, followed by Europe at around 30%. The Asia-Pacific region is expected to grow rapidly, contributing about 20% of the market share[2].
• Market Size and Revenue: The market is projected to exceed $2 billion in revenue, driven by the diverse product offerings and increasing demand for diagnostic imaging procedures[2].

Emerging Trends

Several trends are shaping the future of the iopamidol injection market:

• Shift Towards Safer Contrast Agents: There is a growing preference for safer and more efficient contrast agents, which is expected to boost iopamidol's market penetration.
• Rise of Minimally Invasive Procedures: The increasing adoption of minimally invasive procedures is driving the demand for high-quality contrast agents like iopamidol.
• Technological Innovations: Advances in radiological technologies and imaging systems are further bolstering the adoption of iopamidol injections in healthcare settings[2].

Key Players and R&D

Major market players are investing heavily in research and development to innovate and improve the efficacy of iopamidol injections. This includes advancements in formulation technologies and the development of new applications for iopamidol in various medical imaging procedures[2].

Regional Outlook

The market is segmented geographically, with North America and Europe being the dominant regions. However, the Asia-Pacific region is expected to witness the fastest growth due to rising healthcare expenditure and improved imaging infrastructure. Key countries in this region include China, Japan, South Korea, and India[2].

Conclusion

Iopamidol-250 is a critical component in modern medical imaging, offering enhanced visualization and diagnostic accuracy. With a strong market outlook, driven by increasing demand for advanced imaging techniques and technological innovations, the future of iopamidol-250 looks promising.

Key Takeaways

• Iopamidol-250 is a non-ionic iodinated contrast agent used in various medical imaging procedures.
• It enhances radiographic efficiency and is indicated for a wide range of intravascular procedures.
• Clinical trials have shown its efficacy and safety profile comparable to other contrast agents.
• The market is projected to grow at a CAGR of 7.4% from 2022 to 2028.
• Emerging trends include a shift towards safer contrast agents and the rise of minimally invasive procedures.
• Key players are investing in R&D to improve product efficacy.

FAQs

Q: What is the primary use of Iopamidol-250 in medical imaging? A: Iopamidol-250 is primarily used to enhance the quality of images in computed tomography (CT) scans, angiography, and other diagnostic imaging techniques.

Q: How does Iopamidol-250 work in the body? A: Iopamidol-250 works by enhancing radiographic efficiency, allowing for clear visualization of internal structures. It is distributed between the circulating blood volume and other extracellular fluid without significant deposition in tissues.

Q: What are the key factors driving the growth of the iopamidol injection market? A: The growth is driven by increasing demand for advanced imaging techniques, advancements in healthcare infrastructure, rising incidences of chronic diseases, and technological innovations in imaging systems.

Q: Which regions are expected to dominate the iopamidol injection market? A: North America is anticipated to dominate the market, followed by Europe and the Asia-Pacific region, which is expected to grow rapidly.

Q: What are the emerging trends in the iopamidol injection market? A: Emerging trends include a shift towards safer and more efficient contrast agents, the rise of minimally invasive procedures, and technological innovations in radiological technologies.

Sources

1. ISOVUE-250 Prescription & Dosage Information - eMPR.com
2. Iopamidol Injection Market, Global Outlook and Forecast 2022-2028 - Reliable Market Forecast
3. IsovueTM Iopamidol Injection USP - e-lactancia.org
4. Comparative Analysis of Image Quality and Adverse Events - PubMed
5. Isovue 250: Package Insert / Prescribing Information - Drugs.com