CLINICAL TRIALS PROFILE FOR ULTRAVIST 300 IN PLASTIC CONTAINER

All Clinical Trials for Ultravist 300 In Plastic Container

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00244140 ↗	Ultravist: Safety and Efficacy in Computed Tomography of Head and Body	Completed	Bayer	Phase 3	2005-10-01	This is a research study involving the use of a contrast agent called Ultravist Injection. Ultravist, the study drug, is used to improve the pictures obtained using computed tomography (CT). Ultravist acts like a dye to make CT pictures brighter and easier to read. In the case of this study, it will be injected into a vein in the patient's arm; from there, it travels through the blood stream and to the areas to be examined. CT scans will then be taken of the patient's head and/or body as ordered by his/her physician. Phase IIIb Study to Document the Safety and Efficacy of Ultravist 370 mg I/ml, When Administered Intravenously, in Volumes up to 162.2 ml, for Clinically Indicated Contrast Enhanced Computed Tomography (CECT) of the Head and/or Body
NCT00876083 ↗	PMS Study Ultravist-IMAGE, IoproMide (UltrAvist) to Gain Further Information on Tolerability and Safety in X-ray Examination	Completed	Bayer		2008-03-01	The purpose of this study is to obtain data on the safety and efficacy of Ultravist application in usual daily use.The radiologist will administer the contrast medium to the patient as he/she would have done without the study. No other examinations will be performed than would have been done routinely.
NCT00926562 ↗	A Safety Comparison of Iopromide and Iodixanol in Renal Impaired Patients	Completed	Chinese PLA General Hospital	Phase 4	2009-02-01	The investigators intend to find out which contrast agent has less kidney toxicity in renal impaired patients undergoing cardiac angiography or percutaneous coronary intervention (PCI).
NCT01206257 ↗	The Safety and toleRability of UltraviSt in Patients Undergoing Cardiac CaTheterization (TRUST)	Completed	Bayer		2010-08-01	This study is to collect the information of Ultravist® in the patients indicated for the coronary angiography or PCI, like rate of ADR in patients, the dose for different indications, image quality to prove Ultravist the good safety and effectivity
NCT01255722 ↗	Xenetix® 350: Comparative Assessment of Image Quality for Coronary CT Angiography	Completed	Guerbet	Phase 4	2010-11-01	The purpose of this study is to demonstrate the (statistical) non-inferiority of iobitridol (Xenetix® 350) when compared to contrast agents with higher iodine concentrations, iopromide (Ultravist® 370) and iomeprol (Iomeron® 400) in terms of coronary CT scan evaluability (quality and interpretability of images).
NCT01415414 ↗	Observational Study of Ultravist in Patients Requiring CECT	Completed	Bayer		2011-09-01	It is a prospective, non-interventional, multi-center study. The primary objective of this study is to evaluate the image quality of Ultravist in patients requiring contrast-enhanced CT considering the routine use in patient population's, region's indication.
NCT01448889 ↗	Normobaric Hyperoxygenation for Prevention of Contrast Induced Nephropathy	Unknown status	Assaf-Harofeh Medical Center	N/A	2009-09-01	Acute renal failure induced by radiographic contrast agents is a known complication of coronary angiography.hypoxia plays a major role in the pathogenesis of Contrast induced nephropathy. The aim of the current study is to investigate the effect of normobaric hyperoxygenation therapy on renal functions in patients at high risk for CIN undergoing coronary angiography. The study is aimed to include 180 consecutive patients with estimated GFR base on the MDRD equation of less than 60 mL/min/1.73 m2 that are candidates for elective coronary angiography. Patients with acute renal failure, acute myocardial infarction, noncompensated congestive heart failure, hemodynamic instability, known sensitivity to contrast media and patients who had been exposed to contrast media during the last 3 months will be excluded. Patients with oxygen blood saturation of less than 94% at room air will also be excluded from the study. Study protocol Patients will be randomly assigned to receive either 100% oxygen by mask (treated group) or breath room air (control group) for duration of 4 hours starting at the beginning of the angiographic procedure. All patients will be treated with 0.9% salin and NAC. Coronary angiography will be performed using nonionic, low osmolar iodine (Ultravist®-370) (Schering, Berlin, Germany). All patients will be hospitalized 1 day before and at least 24 hours following angiography. Blood samples for urea, creatinine and cystatin- C will be drawn on admission, 6, 24 and 48 hours after coronary angiography. Urine sample will be taken 24 hours before angiography and 6, 24 and 48 hours post angiography. In those urine samples the ratio between creatinine to Isoprostanes and NO will be evaluated.

Clinical Trial Conditions for Ultravist 300 In Plastic Container

Condition Name

Condition Name for Ultravist 300 In Plastic Container
Intervention	Trials
Diagnostic Imaging	3
Kidney Failure, Chronic	2
Nephropathy	1
Venous Thromboembolism	1

Condition MeSH

Condition MeSH for Ultravist 300 In Plastic Container
Intervention	Trials
Renal Insufficiency	2
Kidney Failure, Chronic	2
Thromboembolism	1
Kidney Diseases	1

Clinical Trial Locations for Ultravist 300 In Plastic Container

Trials by Country

Trials by Country for Ultravist 300 In Plastic Container
Location	Trials
China	23
United States	11
Korea, Republic of	3
Colombia	2
France	1

Trials by US State

Trials by US State for Ultravist 300 In Plastic Container
Location	Trials
South Carolina	1
Pennsylvania	1
Ohio	1
New York	1
Michigan	1

Clinical Trial Progress for Ultravist 300 In Plastic Container

Clinical Trial Phase

Clinical Trial Phase for Ultravist 300 In Plastic Container
Clinical Trial Phase	Trials
Phase 4	4
Phase 3	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for Ultravist 300 In Plastic Container
Clinical Trial Phase	Trials
Completed	8
Unknown status	2
Not yet recruiting	1

Clinical Trial Sponsors for Ultravist 300 In Plastic Container

Sponsor Name

Sponsor Name for Ultravist 300 In Plastic Container
Sponsor	Trials
Bayer	5
Chinese PLA General Hospital	1
Guerbet	1

Sponsor Type

Sponsor Type for Ultravist 300 In Plastic Container
Sponsor	Trials
Other	7
Industry	7

ULTRAVIST 300: Clinical Trials, Market Analysis, and Projections

Introduction

ULTRAVIST 300, an injectable contrast agent containing the active ingredient iopromide, is widely used in various radiographic procedures. This article delves into the recent clinical trials, market analysis, and future projections for ULTRAVIST 300.

Clinical Trials and Approvals

Recent Approvals

The FDA has recently expanded the approval of ULTRAVIST 300 to include contrast-enhanced mammography. This approval is based on a prospective study involving 216 women with Breast Imaging Reporting and Data System (BI-RADS) 3, 4, or 5 findings on mammography. The study demonstrated the efficacy of ULTRAVIST 300 in visualizing known or suspected breast lesions, with 83% of the lesions evaluated showing intense contrast[4].

Study Outcomes

In the study, 226 lesions were evaluated, with 98 identified as malignant. The visualization of lesion contrast was scored on a 4-point scale, highlighting the effectiveness of ULTRAVIST 300 in enhancing breast imaging. This expansion in approval provides healthcare professionals with an additional tool for diagnosing and managing breast lesions[4].

Indications and Dosage

Indications

ULTRAVIST 300 is indicated for various radiographic procedures, including:

• Excretory urography
• Contrast computed tomography (CT) imaging of the head and body
• Intra-arterial digital subtraction angiography (IA-DSA)
• Cerebral arteriography and peripheral arteriography
• Coronary arteriography and left ventriculography
• Visceral angiography and aortography
• Peripheral venography
• Contrast-enhanced mammography[2][5].

Dosage

The dosage of ULTRAVIST 300 varies depending on the procedure:

• For CT imaging of the head, 50–200 mL is typically administered.
• For CT imaging of the body, doses range from 50–200 mL, with multiple phase contrasts using a power injector.
• For excretory urography, 40–70 mL is recommended.
• For contrast-enhanced mammography, 1.5 mL/kg is administered using a power injector[1][2].

Pharmacokinetics and Safety

Distribution and Elimination

ULTRAVIST 300 is primarily eliminated through the kidneys, with a mean total renal clearance of 107 mL/min. It has a steady-state volume of distribution of 16 L and is only 1% bound to plasma proteins[1].

Contraindications and Precautions

ULTRAVIST 300 is contraindicated for intrathecal use and in patients with certain conditions such as asthma, cyanotic and acyanotic heart disease, congestive heart failure, and severe renal impairment. It is also not recommended for children under 2 years old, pregnant women, and nursing mothers without careful consideration[1][2].

Adverse Reactions

Common adverse reactions include headache, nausea, injection site reactions, vasodilatation, vomiting, back pain, and urinary urgency. Serious reactions can include anaphylactoid reactions, acute kidney injury, and cardiovascular reactions[1].

Market Analysis

Current Market

The global market for contrast agents, including ULTRAVIST 300, is influenced by the increasing demand for diagnostic imaging procedures. The expansion of ULTRAVIST 300 into contrast-enhanced mammography further strengthens its market position.

Market Projections

The clinical trial packaging market, which includes packaging for contrast agents like ULTRAVIST 300, is projected to grow significantly. From $4.13 billion in 2024, the market is expected to reach $8.54 billion by 2032, with a CAGR of 9.51%. This growth is driven by the increasing number of clinical trials, especially post-COVID-19, and the demand for innovative and sustainable packaging solutions[3].

Impact of Regulatory Changes

Stringent Regulations

The market growth of ULTRAVIST 300 and other contrast agents is somewhat hampered by stringent government regulations, particularly those related to plastic usage and environmental sustainability. However, these regulations also drive the adoption of more sustainable packaging materials, which can be a positive trend for the market[3].

Industry Trends and Innovations

Smart Packaging and Wearable Devices

The adoption of smart packaging and wearable devices in clinical trials is emerging as a key trend. This innovation enhances the efficiency and accuracy of clinical trials, which in turn supports the growth of the contrast agent market[3].

Increased R&D and Mergers

The pharmaceutical industry's increased investments in research and development, along with mergers and acquisitions, are propelling the growth of the clinical trial packaging sector. This includes a focus on contract manufacturing organizations for clinical trials, further boosting the market for ULTRAVIST 300 and similar products[3].

Key Takeaways

• Expanded Approval: ULTRAVIST 300 has been approved for contrast-enhanced mammography, expanding its clinical applications.
• Clinical Trials: Recent studies have demonstrated the efficacy of ULTRAVIST 300 in visualizing breast lesions.
• Market Growth: The market for contrast agents is projected to grow significantly, driven by increasing clinical trials and demand for innovative packaging.
• Regulatory Impact: Stringent regulations on plastic usage and environmental sustainability are shaping the market but also driving innovation.
• Industry Trends: The adoption of smart packaging and wearable devices, along with increased R&D and mergers, are key trends supporting market growth.

FAQs

What is ULTRAVIST 300 used for?

ULTRAVIST 300 is an injectable contrast agent used in various radiographic procedures, including excretory urography, CT imaging, angiography, and contrast-enhanced mammography.

What is the recent FDA approval for ULTRAVIST 300?

The FDA has recently approved ULTRAVIST 300 for contrast-enhanced mammography to visualize known or suspected breast lesions.

What are the common adverse reactions to ULTRAVIST 300?

Common adverse reactions include headache, nausea, injection site reactions, vasodilatation, vomiting, back pain, and urinary urgency.

How is ULTRAVIST 300 eliminated from the body?

ULTRAVIST 300 is primarily eliminated through the kidneys, with a mean total renal clearance of 107 mL/min.

What are the market projections for the clinical trial packaging sector?

The clinical trial packaging market, which includes packaging for contrast agents like ULTRAVIST 300, is projected to grow from $4.13 billion in 2024 to $8.54 billion by 2032, with a CAGR of 9.51%.

References

1. ULTRAVIST 300 Prescription & Dosage Information - MPR
2. ULTRAVIST English Product Monograph - Bayer
3. Clinical Trial Packaging Market Size & Detailed Analysis - Fortune Business Insights
4. Ultravist Approval Expanded to Include Contrast-Enhanced Mammography - Cancer Therapy Advisor
5. ULTRAVIST 300 IN PLASTIC CONTAINER - PharmaCompass