CLINICAL TRIALS PROFILE FOR OPTIRAY 320

All Clinical Trials for OPTIRAY 320

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00793182 ↗	Effects of Contrast Media on Subjects With Stable Reduced Renal Function Undergoing Contrast-Enhanced Computed Tomography	Terminated	Guerbet	Phase 4	2009-01-01	The purpose of this study is to evaluate the contrast-induced nephropathy (CIN) rate in subjects randomized to receive either Ioversol or Iodixanol for contrast-enhanced computed tomography.
NCT00793182 ↗	Effects of Contrast Media on Subjects With Stable Reduced Renal Function Undergoing Contrast-Enhanced Computed Tomography	Terminated	Mallinckrodt	Phase 4	2009-01-01	The purpose of this study is to evaluate the contrast-induced nephropathy (CIN) rate in subjects randomized to receive either Ioversol or Iodixanol for contrast-enhanced computed tomography.
NCT03631771 ↗	Pediatric Risk of Hypothyroidism With Iodinated Contrast Media	Not yet recruiting	Bayer	Phase 4	2022-03-01	This is a Phase 4 multicenter prospective study to estimate the proportion of patients aged birth to 3 years who develop hypothyroidism within 6 months after receiving intravascular iohexol (Omnipaque™), iodixanol (Visipaque™), iopromide (Ultravist®), or ioversol (Optiray®) as the iodinated contrast medium (ICM) for clinical evaluation during an ICM-enhanced diagnostic imaging procedure.
NCT03631771 ↗	Pediatric Risk of Hypothyroidism With Iodinated Contrast Media	Not yet recruiting	Duke Clinical Research Institute	Phase 4	2022-03-01	This is a Phase 4 multicenter prospective study to estimate the proportion of patients aged birth to 3 years who develop hypothyroidism within 6 months after receiving intravascular iohexol (Omnipaque™), iodixanol (Visipaque™), iopromide (Ultravist®), or ioversol (Optiray®) as the iodinated contrast medium (ICM) for clinical evaluation during an ICM-enhanced diagnostic imaging procedure.
NCT03631771 ↗	Pediatric Risk of Hypothyroidism With Iodinated Contrast Media	Not yet recruiting	Guerbet/Liebel-Flarsheim	Phase 4	2022-03-01	This is a Phase 4 multicenter prospective study to estimate the proportion of patients aged birth to 3 years who develop hypothyroidism within 6 months after receiving intravascular iohexol (Omnipaque™), iodixanol (Visipaque™), iopromide (Ultravist®), or ioversol (Optiray®) as the iodinated contrast medium (ICM) for clinical evaluation during an ICM-enhanced diagnostic imaging procedure.
NCT03631771 ↗	Pediatric Risk of Hypothyroidism With Iodinated Contrast Media	Not yet recruiting	GE Healthcare	Phase 4	2022-03-01	This is a Phase 4 multicenter prospective study to estimate the proportion of patients aged birth to 3 years who develop hypothyroidism within 6 months after receiving intravascular iohexol (Omnipaque™), iodixanol (Visipaque™), iopromide (Ultravist®), or ioversol (Optiray®) as the iodinated contrast medium (ICM) for clinical evaluation during an ICM-enhanced diagnostic imaging procedure.
NCT04733092 ↗	Safety and Efficacy of a Lipiodol Emulsion for the Embolization of Hypervascularizations in Patients With Knee Pain (LipioJoint1)	Recruiting	Guerbet	Phase 1	2021-03-03	Knee osteoarthritis is a common cause of disability in patients who are often young and active. Surgery being an option only for the most severe cases, there is little alternative in case of failure of recommended medication. Inflammatory hypervascularization of the joint is a known source of pain. Temporary embolization of intra-arterial inflammatory hypervascularization has been used since 2012 with good results on pain relief to treat patients with musculoskeletal disorders that are resistant to conventional treatments. Lipiodol® has transient embolizing properties when in emulsion with a contrast agent. It has been used as an emulsion with chemotherapy for the treatment of metastases and primary intra-arterial liver cancer (chemo-embolization) for many years without serious side effects. We hypothesized that Lipiodol® in emulsion could serve as a temporary embolization agent for the treatment of inflammatory hypervascularization responsible for musculoskeletal disorders in humans.

Clinical Trial Conditions for OPTIRAY 320

Condition Name

Condition Name for OPTIRAY 320
Intervention	Trials
Knee Osteoarthritis	1
Renal Impairment	1
Hypothyroidism	1

Condition MeSH

Condition MeSH for OPTIRAY 320
Intervention	Trials
Renal Insufficiency	1
Osteoarthritis, Knee	1
Osteoarthritis	1
Hypothyroidism	1

Clinical Trial Locations for OPTIRAY 320

Trials by Country

Trials by Country for OPTIRAY 320
Location	Trials
United States	11
France	1

Trials by US State

Trials by US State for OPTIRAY 320
Location	Trials
Arizona	1
Alabama	1
Texas	1
Pennsylvania	1
Ohio	1

Clinical Trial Progress for OPTIRAY 320

Clinical Trial Phase

Clinical Trial Phase for OPTIRAY 320
Clinical Trial Phase	Trials
Phase 4	2
Phase 1	1

Clinical Trial Status

Clinical Trial Status for OPTIRAY 320
Clinical Trial Phase	Trials
Not yet recruiting	1
Recruiting	1
Terminated	1

Clinical Trial Sponsors for OPTIRAY 320

Sponsor Name

Sponsor Name for OPTIRAY 320
Sponsor	Trials
Guerbet	2
Mallinckrodt	1
Bayer	1

Sponsor Type

Sponsor Type for OPTIRAY 320
Sponsor	Trials
Industry	5
Other	3

OPTIRAY 320 Market Analysis and Financial Projection

OPTIRAY 320: Clinical Trials, Market Analysis, and Projections

Introduction

OPTIRAY 320, also known as ioversol 68% injectable solution, is a low-osmolality nonionic contrast medium widely used in various medical imaging procedures. Here, we will delve into the clinical trials, market analysis, and projections for this crucial diagnostic tool.

Clinical Trials and Efficacy

Safety and Tolerance

Clinical studies have consistently shown that OPTIRAY 320 is well tolerated by patients. An open-label noncomparative clinical study involving 42 adult patients undergoing contrast-enhanced CT scans of the chest, abdomen, and pelvis demonstrated that the drug was safe and effective. None of the patients reported pain from the contrast agent, with only mild or moderate sensations of heat noted[1].

Diagnostic Quality

The quality of CT scans obtained using OPTIRAY 320 was judged to be diagnostic in all 42 patients, with 35 patients having excellent quality scans and seven having good quality scans. This indicates the high efficacy of OPTIRAY 320 in enhancing image quality for diagnostic purposes[1].

Indications and Clinical Use

OPTIRAY 320 is indicated for a wide range of medical imaging procedures, including angiography throughout the cardiovascular system, contrast-enhanced computed tomographic imaging of the head and body, and intravenous excretory urography. It is also used in children for angiocardiography and contrast-enhanced CT scans of the head and body[3][4].

Market Analysis

Market Segmentation

The ioversol market, which includes OPTIRAY 320, is segmented based on type, application, and geography. The types include various concentrations of ioversol solutions such as OPTIRAY 160, OPTIRAY 240, OPTIRAY 300, OPTIRAY 320, and OPTIRAY 350. Applications include X-ray, CT scans, brain disorders, blood vessel disorders, heart disorders, and others. Geographically, the market spans North America, Europe, Asia-Pacific, and LAMEA (Latin America, Middle East, and Africa)[2][5].

Key Players

The ioversol market is highly competitive, with key players such as Jiangsu Hengrui Medicine Co, Mallinckrodt Pharmaceuticals, Liebel-Flarsheim Company LLC, Ultraject, and Guerbet. These companies employ various strategies including acquisitions, mergers, and regional expansion to increase their market share[5].

Regional Market

North America is forecasted to occupy a major share in the ioversol market, followed by other regions. The market analysis includes detailed segmentations for regions such as the U.S., Canada, Mexico, U.K., Germany, France, Italy, Spain, China, India, Japan, South Korea, Brazil, Argentina, GCC Countries, and South Africa[5].

Market Projections

Market Size and Growth

The global ioversol market, including OPTIRAY 320, has shown significant growth and is expected to continue this trend. As of 2020, the market demand was substantial, and it is predicted to reach higher figures by 2028 at a notable CAGR. The market size is forecasted based on revenue in USD million, with detailed historical data from 2016 to 2020 and projections from 2021 to 2028[5].

Market Drivers and Restraints

The market growth is driven by increasing demand for advanced diagnostic imaging, technological advancements in medical imaging, and the expanding need for contrast agents in various medical procedures. However, the market also faces restraints such as the high cost of contrast agents, potential adverse reactions, and regulatory challenges[5].

Adverse Reactions and Safety Considerations

Common Adverse Reactions

Adverse reactions following the use of OPTIRAY 320 are usually mild to moderate and of short duration, resolving spontaneously without treatment. Common reactions include sensations of warmth and pain. However, serious and life-threatening reactions, mostly of cardiovascular origin, have been associated with the administration of iodine-containing contrast media[4].

Contraindications and Warnings

There are no specific contraindications for OPTIRAY 320, but serious adverse reactions have been reported due to inadvertent intrathecal administration of iodinated contrast media. It is also advised to consider temporarily discontinuing nursing if the contrast medium is administered to nursing women due to potential adverse reactions[4].

Key Takeaways

• Clinical Efficacy: OPTIRAY 320 has been proven to be safe and effective in clinical trials, providing high-quality diagnostic images.
• Market Segmentation: The market is segmented by type, application, and geography, with North America forecasted to hold a significant share.
• Market Growth: The global ioversol market is expected to grow significantly by 2028, driven by increasing demand for advanced diagnostic imaging.
• Safety Considerations: While generally well-tolerated, OPTIRAY 320 can cause mild to moderate adverse reactions, and serious reactions are possible in rare cases.

FAQs

Q: What is OPTIRAY 320 used for?

A: OPTIRAY 320 is used for various medical imaging procedures, including angiography, contrast-enhanced CT scans of the head and body, and intravenous excretory urography.

Q: Is OPTIRAY 320 safe for patients?

A: Clinical trials have shown that OPTIRAY 320 is well tolerated by patients, with most adverse reactions being mild to moderate.

Q: Which regions dominate the ioversol market?

A: North America is forecasted to occupy a major share in the ioversol market, followed by other regions such as Europe, Asia-Pacific, and LAMEA.

Q: What are the common adverse reactions associated with OPTIRAY 320?

A: Common adverse reactions include sensations of warmth and pain. Serious reactions, mostly of cardiovascular origin, can occur but are rare.

Q: Are there any contraindications for OPTIRAY 320?

A: There are no specific contraindications, but serious adverse reactions can occur with inadvertent intrathecal administration, and caution is advised for nursing women.

Sources

1. Ioversol 320: a new nonionic, water-soluble contrast medium for ... - PubMed
2. Global Ioversol Market - Allied Market Research
3. OPTIRAY - Health Canada
4. 320 Optiray® Pharmacy Bulk Package - NCBI
5. Ioversol Market Size, Share, Industry Growth Analysis Report ... - Market Research Store