CLINICAL TRIALS PROFILE FOR ISOVUE-370

All Clinical Trials for Isovue-370

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-370

Condition Name

Condition Name for Isovue-370
Intervention	Trials
Diabetes Mellitus	2
Peripheral Arterial Occlusive Disease	2
Contrast Induced Nephropathy	1
Moderate to Severe Chronic Kidney Disease	1

Condition MeSH

Condition MeSH for Isovue-370
Intervention	Trials
Kidney Diseases	3
Renal Insufficiency	3
Arterial Occlusive Diseases	2
Myocardial Ischemia	2

Clinical Trial Locations for Isovue-370

Trials by Country

Trials by Country for Isovue-370
Location	Trials
United States	17
United Kingdom	1
Canada	1

Trials by US State

Trials by US State for Isovue-370
Location	Trials
New Jersey	11
New York	1
Texas	1
Nebraska	1
California	1

Clinical Trial Progress for Isovue-370

Clinical Trial Phase

Clinical Trial Phase for Isovue-370
Clinical Trial Phase	Trials
Phase 4	13
Phase 3	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for Isovue-370
Clinical Trial Phase	Trials
Completed	14
Recruiting	3
Terminated	2

Clinical Trial Sponsors for Isovue-370

Sponsor Name

Sponsor Name for Isovue-370
Sponsor	Trials
Bracco Diagnostics, Inc	10
GE Healthcare	4
i3 Statprobe	2

Sponsor Type

Sponsor Type for Isovue-370
Sponsor	Trials
Industry	21
Other	9
NIH	1

ISOVUE-370: Clinical Trials, Market Analysis, and Projections

Introduction

ISOVUE-370, a non-ionic radiopaque contrast agent, is widely used in various medical imaging procedures, including angiography, computed tomography (CT), and excretory urography. This article provides an update on clinical trials, market analysis, and projections for ISOVUE-370.

Clinical Trials and Efficacy

ISOVUE-370 has been extensively studied in clinical trials to evaluate its efficacy and safety in different medical imaging procedures.

Radiopacity and Accuracy

A recent quantitative study compared the radiopacity of ISOVUE-370 with other contrast agents. The results showed that ISOVUE-370 provides the highest Hounsfield unit (HU) radiopacity and the most accurate aneurysm measurements compared to other agents like Visipaque 320 and Omnipaque 300[1].

Clinical Indications

ISOVUE-370 is indicated for a wide range of procedures, including angiography throughout the cardiovascular system, cerebral and peripheral arteriography, coronary arteriography, ventriculography, and intravenous contrast enhancement in CT imaging of the head and body. It is also used in pediatric angiocardiography and selective visceral arteriography[4].

Safety Profile

Clinical trials have demonstrated that ISOVUE-370 has a favorable safety profile. It does not significantly bind to serum or plasma proteins and does not cross the blood-brain barrier to a significant extent. Additionally, there is no evidence of in vivo complement activation in normal subjects[2][3].

Market Analysis

Current Market Status

ISOVUE-370 is currently marketed by Bracco Diagnostics and is available in various countries. However, recent reports indicate a temporary shortage due to an increase in demand, which is expected to be resolved by mid-December 2024[5].

Market Demand

The demand for ISOVUE-370 is driven by its wide range of clinical indications and its superior radiopacity compared to other contrast agents. The increasing need for precise and accurate medical imaging, particularly in cardiovascular and neurological procedures, contributes to the high demand for this drug.

Competitive Landscape

The market for radiopaque contrast agents is competitive, with other agents like Visipaque 320 and Omnipaque 300 also being widely used. However, ISOVUE-370's superior radiopacity and accuracy in aneurysm measurements give it a competitive edge. Additionally, its suitability for patients with chronic kidney or cardiac disease, similar to Visipaque 320 and Omnipaque 300 at 100% concentration, makes it a preferred choice in certain patient populations[1].

Market Projections

Future Demand

Given the ongoing advancements in medical imaging technologies and the increasing prevalence of cardiovascular and neurological diseases, the demand for ISOVUE-370 is expected to continue growing. The drug's versatility and safety profile are likely to maintain its market position.

Market Trends

The trend towards more precise and minimally invasive diagnostic procedures is expected to drive the demand for high-quality contrast agents like ISOVUE-370. Additionally, the integration of artificial intelligence and machine learning in medical imaging may further enhance the utility of ISOVUE-370 by improving image analysis and diagnostic accuracy.

Economic Factors

The economic factors influencing the market include the cost of the drug, healthcare policies, and reimbursement rates. ISOVUE-370, being a premium product, may face competition from generic or lower-cost alternatives. However, its proven efficacy and safety are likely to justify its cost and maintain market share.

Regulatory Considerations

Approvals and Labeling

ISOVUE-370 has been approved for various indications and is labeled for intravascular use. It is not approved for intrathecal use, and there are specific warnings regarding its use in patients with certain medical conditions, such as recent cholecystographic agents in patients with hepatic or biliary disorders[4].

Compliance and Safety Monitoring

Regulatory bodies closely monitor the safety and efficacy of ISOVUE-370 through post-marketing surveillance. Any adverse events or safety concerns are promptly addressed to ensure patient safety.

Conclusion

ISOVUE-370 remains a critical component in medical imaging due to its high radiopacity, accuracy, and wide range of clinical indications. Despite temporary shortages, the market demand is expected to remain strong, driven by advancements in medical imaging and the increasing need for precise diagnostic tools.

Key Takeaways

• High Radiopacity: ISOVUE-370 provides the highest HU radiopacity among compared contrast agents.
• Clinical Indications: It is indicated for various angiographic and CT imaging procedures.
• Safety Profile: The drug has a favorable safety profile with minimal binding to serum proteins and no significant crossing of the blood-brain barrier.
• Market Demand: The demand is driven by its clinical efficacy and the increasing need for precise medical imaging.
• Regulatory Compliance: It is approved for intravascular use with specific labeling and safety warnings.

FAQs

What are the primary indications for ISOVUE-370?

ISOVUE-370 is indicated for angiography throughout the cardiovascular system, including cerebral and peripheral arteriography, coronary arteriography, ventriculography, and intravenous contrast enhancement in CT imaging of the head and body[4].

How does ISOVUE-370 compare to other contrast agents in terms of radiopacity?

ISOVUE-370 provides the highest Hounsfield unit (HU) radiopacity compared to other agents like Visipaque 320 and Omnipaque 300[1].

What are the safety considerations for ISOVUE-370?

ISOVUE-370 is not approved for intrathecal use and has specific warnings regarding its use in patients with certain medical conditions, such as recent cholecystographic agents in patients with hepatic or biliary disorders[4].

Is ISOVUE-370 currently facing any market shortages?

Yes, there is a temporary shortage of ISOVUE-370 due to an increase in demand, which is expected to be resolved by mid-December 2024[5].

What is the expected future demand for ISOVUE-370?

The demand for ISOVUE-370 is expected to continue growing due to ongoing advancements in medical imaging technologies and the increasing prevalence of cardiovascular and neurological diseases.

References

1. Mehta, A., Roa, J. A., Cannavale, K., Sur, S., & Singh, I. P. (2023). Differences in radiopacity among CT contrast agents and concentrations: A quantitative study. Journal of Neuroimaging, 33(4), 13149.
2. FDA Label for ISOVUE-370. (2017). Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018735s057lbl.pdf
3. IsovueTM Iopamidol Injection USP. (2017). Retrieved from https://www.e-lactancia.org/media/papers/Ipamidol-DS-Bracco2017.pdf
4. ISOVUE-370 Prescription & Dosage Information. Retrieved from https://www.empr.com/drug/isovue-370/
5. Drug Shortage Report for ISOVUE 370 INJECTION. (2024). Retrieved from https://www.drugshortagescanada.ca/shortage/243710