You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: May 25, 2025

CLINICAL TRIALS PROFILE FOR OPTISON


✉ Email this page to a colleague

« Back to Dashboard


All Clinical Trials for Optison

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00186953 ↗ Determination of a Safe Dose of Optison in Pediatric Patients With Solid Tumors Completed St. Jude Children's Research Hospital Phase 1 2002-06-01 St. Jude Children's Research Hospital is studying ways to make ultrasound images clearer - to be able to see blood vessels, body structures, and tumors better. Ultrasound uses sound waves to create pictures, allowing doctors and other medical professionals to "see" inside the body. Researchers are studying a contrast agent (like a dye) called Optison™. St. Jude Children's Research Hospital researchers want to learn the best and safest dose of this ultrasound "dye."
NCT00286559 ↗ Assessing Myocardial Blood Flow and Blood Flow Reserve by Transoesophageal Echocardiography (TEE) Withdrawn University Hospital, Basel, Switzerland Phase 1/Phase 2 2006-08-01 Until today it was not possible to reliably assess the function of a new bypass, i.e., to measure myocardial perfusion. Measuring intramyocardial blood flow directly after revascularisation would greatly improve the assessment of graft function. With transthoracic contrast echocardiography, myocardial perfusion can be reliably assessed, as it has been shown in numerous studies. In the first part of the study the investigators will clarify methodological aspects of contrast echocardiography. In the second part they will analyze the validity of contrast TEE in the operating room.
NCT00580580 ↗ Detection of Coronary Stenosis With Intravenous Microbubbles Withdrawn University of Nebraska N/A 2012-02-01 To detect coronary artery disease by both coronary and carotid artery imaging and myocardial perfusion imaging using a new low mechanical index real time system.
NCT00730964 ↗ A Prospective Surveillance Trial to Evaluate the Safety of Optison in Clinical Practice. Completed GE Healthcare Phase 4 2008-05-01 This prospective surveillance trial will gather safety information for Optison when it is used in routine practice.
NCT00878878 ↗ Evaluate Effect of Optison on Pulmonary Artery Systolic Pressure (PASP) and Pulmonary Vascular Resistance (PVR). Completed ICON Clinical Research Phase 4 2009-03-01 The design of this study is to conduct a comprehensive safety evaluation of the pulmonary hemodynamic effects of Optison. The study is being conducted in subjects referred for cardiac catheterization for clinical reasons.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Optison

Condition Name

Condition Name for Optison
Intervention Trials
Coronary Artery Disease 2
Heart Transplantation 1
Transplantation, Kidney 1
Abdominal Neoplasms 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for Optison
Intervention Trials
Myocardial Ischemia 2
Coronary Disease 2
Coronary Artery Disease 2
Carcinoma 2
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for Optison

Trials by Country

Trials by Country for Optison
Location Trials
United States 26
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for Optison
Location Trials
Pennsylvania 4
Arizona 2
Massachusetts 2
Utah 2
Minnesota 2
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for Optison

Clinical Trial Phase

Clinical Trial Phase for Optison
Clinical Trial Phase Trials
Phase 4 5
Phase 2 4
Phase 1/Phase 2 3
[disabled in preview] 7
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for Optison
Clinical Trial Phase Trials
Completed 9
Recruiting 4
Withdrawn 3
[disabled in preview] 3
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for Optison

Sponsor Name

Sponsor Name for Optison
Sponsor Trials
GE Healthcare 6
Thomas Jefferson University 2
Mayo Clinic 2
[disabled in preview] 2
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for Optison
Sponsor Trials
Other 19
Industry 11
NIH 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trials, Market Analysis, and Projections for Optison

Introduction

Optison, also known as Perflutren Protein-Type A Microspheres Injectable Suspension, is an FDA-approved ultrasound contrast agent used primarily in echocardiography. Here, we will delve into the current state of clinical trials, market analysis, and future projections for Optison.

Clinical Trials and Safety Profile

Current Clinical Use

Optison is indicated for use in patients with suboptimal echocardiograms to opacify the left ventricle and improve the delineation of the left ventricular endocardial borders. It has been extensively used since its FDA approval in 1998[2].

Adverse Events

Clinical trials have shown that Optison is generally well-tolerated. The most frequently reported adverse reactions include headache, nausea and/or vomiting, warm sensation or flushing, and dizziness. Serious adverse events are rare, with only 16 serious events reported since 1998, out of over 1 million administered doses[2][5].

Off-Label Use

Optison is also being explored for off-label indications, such as in the evaluation of renal masses. In a study evaluating the use of Optison in detecting renal cell carcinoma (RCC) recurrence post-cryoablation, patients received Optison injections followed by 2D and 3D contrast-enhanced ultrasound (CEUS) exams. The study aims to assess the safety and efficacy of CEUS in this context and to compare 2D and 3D CEUS techniques[1].

Market Analysis

Market Reintroduction

After a temporary halt in supply due to manufacturing difficulties in 2009, GE Healthcare relaunched Optison in 2010 following a thorough review and revision of the manufacturing process. This move ensured a stable supply of the product to the market[2].

Manufacturing Approval

In 2013, GE Healthcare received FDA approval to manufacture Optison in-house, allowing the company to supply the product directly to the US and European markets from its facility in Oslo, Norway[3].

Market Impact

The reintroduction and in-house manufacturing of Optison have been significant for the diagnostic ultrasound market. Optison's benefits include fast preparation time, ease of use, portability, and flexible dosing, making it a valuable tool for improving the accuracy and reliability of echocardiograms without exposing patients to ionizing radiation or dye[2].

Market Projections

Current Market Position

Optison remains a crucial tool in echocardiography, particularly in cases where non-contrast images are suboptimal. The American Society of Echocardiography (ASE) recommends the use of contrast agents like Optison when two or more left ventricular wall segments are not visible on non-contrast images[2].

Future Trends

The demand for ultrasound contrast agents is expected to grow as advancements in medical imaging and diagnostic techniques continue. The increasing focus on precision medicine and the integration of omics technologies in clinical trials could also drive the demand for precise diagnostic tools like Optison, although this is more indirect as omics technologies are primarily related to genetic and molecular diagnostics[4].

Competitive Landscape

The market for ultrasound contrast agents is competitive, but Optison's established safety profile and efficacy, combined with GE Healthcare's robust manufacturing and distribution capabilities, position it strongly in the market. Collaborations with innovators like SonoThera, which are exploring new applications for Optison in gene therapy, further enhance its potential[5].

Collaborations and New Applications

Gene Therapy

GE Healthcare has entered into an agreement with SonoThera to use Optison with their ultrasound-guided gene therapy platform. This collaboration aims to address key delivery challenges in gene therapy and aligns with GE Healthcare's vision of providing precise and effective therapeutic solutions[5].

Key Takeaways

  • Clinical Use: Optison is primarily used in echocardiography to enhance left ventricular opacification and border delineation.
  • Safety Profile: Optison is generally well-tolerated, with rare serious adverse events.
  • Market Position: Optison is a significant player in the diagnostic ultrasound market, especially for suboptimal echocardiograms.
  • Future Trends: Growing demand for precise diagnostic tools and potential new applications in gene therapy are expected to drive its market.
  • Collaborations: Partnerships with companies like SonoThera are expanding Optison's potential beyond traditional echocardiography.

FAQs

Q: What is Optison used for?

Optison is used as an ultrasound contrast agent to opacify the left ventricle and improve the delineation of the left ventricular endocardial borders in patients with suboptimal echocardiograms.

Q: What are the common adverse reactions associated with Optison?

The most frequently reported adverse reactions include headache, nausea and/or vomiting, warm sensation or flushing, and dizziness.

Q: Has Optison been used in any off-label indications?

Yes, Optison is being explored for off-label use in evaluating renal masses and detecting renal cell carcinoma recurrence post-cryoablation.

Q: Why was Optison temporarily unavailable in the market?

Optison was temporarily unavailable due to manufacturing difficulties in 2009 but was relaunched in 2010 after revisions to the manufacturing process.

Q: What are the potential new applications for Optison?

Optison is being explored for use in gene therapy through collaborations with companies like SonoThera.

Sources

  1. TWO AND THREE DIMENSIONAL CONTRAST-ENHANCED ULTRASOUND FOR DETECTION OF RENAL CELL CARCINOMA RECURRENCE POST CRYOABLATION. ClinicalTrials.gov.
  2. GE Relaunches Optison Contrast Agent. DAIC.
  3. GE Healthcare Receives Approval for Its Own Manufacturing of Optison. FierceHealthcare.
  4. Omics-based Clinical Trials Market Size to Hit USD 70.92 Billion by 2034. Biospace.
  5. PDx-US-CON-Optison_SonoThera. GE Healthcare.
Last updated: 2024-12-31

More… ↓

⤷  Try for Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.