CLINICAL TRIALS PROFILE FOR PERFLUTREN

All Clinical Trials for Perflutren

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00398281 ↗	Dutasteride Followed By Ultrasound-Guided Biopsy in Finding Prostate Cancer	Completed	National Cancer Institute (NCI)	Phase 3	2006-11-01	RATIONALE: Diagnostic procedures, such as ultrasound-guided biopsy, may help find prostate cancer. Dutasteride may improve the ability of ultrasound-guided biopsy to find prostate cancer. It is not yet known whether dutasteride followed by ultrasound-guided biopsy is more effective than a placebo followed by ultrasound-guided biopsy in finding prostate cancer. PURPOSE: This randomized phase III trial is studying dutasteride and ultrasound-guided biopsy to see how well they find prostate cancer compared with a placebo and ultrasound-guided biopsy.
NCT00398281 ↗	Dutasteride Followed By Ultrasound-Guided Biopsy in Finding Prostate Cancer	Completed	Sidney Kimmel Cancer Center at Thomas Jefferson University	Phase 3	2006-11-01	RATIONALE: Diagnostic procedures, such as ultrasound-guided biopsy, may help find prostate cancer. Dutasteride may improve the ability of ultrasound-guided biopsy to find prostate cancer. It is not yet known whether dutasteride followed by ultrasound-guided biopsy is more effective than a placebo followed by ultrasound-guided biopsy in finding prostate cancer. PURPOSE: This randomized phase III trial is studying dutasteride and ultrasound-guided biopsy to see how well they find prostate cancer compared with a placebo and ultrasound-guided biopsy.
NCT00507806 ↗	Microbubble-Enhanced Clotbust Treatment of Acute Ischemic Stroke	Terminated	ImaRx Therapeutics	Phase 1/Phase 2	2005-03-01	The study is designed to examine the safety, tolerability, and activity of a combination of microbubbles (perflutren lipid microsphere [Definity®]) and continuous monitoring with 2 MHz transcranial Doppler ultrasound (TCD) as an adjunctive therapy to tissue plasminogen activator (tPA) treatment in subjects with acute ischemic stroke.
NCT00584402 ↗	Contrast Sonography for Evaluation of Liver Tumors Prior to Radiofrequency Ablation	Completed	University of California, Davis	N/A	2007-04-01	The purpose of this study is to determine the efficacy of the Definity (perflutren lipid microsphere Injectable Suspension) ultrasound contrast agent in identifying small tumors (hepatomas & metastases) within the liver. Primary objective: To estimate the increase in conspicuity of small intrahepatic tumors with contrast-enhanced sonography Secondary Objectives: To estimate the effect of tumor type, size, location and depth on the conspicuity of small tumors on contrast-enhanced sonography
NCT00626873 ↗	Contrast-Enhanced Ultrasonography in Diagnosing Early-Stage Ovarian Cancer in Patients With an Adnexal Mass Undergoing Surgery to Remove the Ovary	Completed	National Cancer Institute (NCI)	Phase 1	2007-01-01	RATIONALE: New diagnostic procedures, such as contrast-enhanced ultrasonography, may be an effective method of finding ovarian cancer. PURPOSE: This clinical trial is studying how well contrast-enhanced ultrasonography works in diagnosing early-stage ovarian cancer in patients with an adnexal mass undergoing surgery to remove the ovary.
NCT00626873 ↗	Contrast-Enhanced Ultrasonography in Diagnosing Early-Stage Ovarian Cancer in Patients With an Adnexal Mass Undergoing Surgery to Remove the Ovary	Completed	Icahn School of Medicine at Mount Sinai	Phase 1	2007-01-01	RATIONALE: New diagnostic procedures, such as contrast-enhanced ultrasonography, may be an effective method of finding ovarian cancer. PURPOSE: This clinical trial is studying how well contrast-enhanced ultrasonography works in diagnosing early-stage ovarian cancer in patients with an adnexal mass undergoing surgery to remove the ovary.

Clinical Trial Conditions for Perflutren

Condition Name

Condition Name for Perflutren
Intervention	Trials
Breast Cancer	3
Hepatocellular Carcinoma	3
Cystic Kidney Disease	2
Prognostic Stage III Breast Cancer AJCC v8	1

Condition MeSH

Condition MeSH for Perflutren
Intervention	Trials
Carcinoma	4
Breast Neoplasms	3
Carcinoma, Hepatocellular	3
Kidney Diseases, Cystic	2

Clinical Trial Locations for Perflutren

Trials by Country

Trials by Country for Perflutren
Location	Trials
United States	24
United Kingdom	3
Taiwan	1
India	1

Trials by US State

Trials by US State for Perflutren
Location	Trials
Pennsylvania	8
California	5
North Carolina	4
Tennessee	2
Nebraska	1

Clinical Trial Progress for Perflutren

Clinical Trial Phase

Clinical Trial Phase for Perflutren
Clinical Trial Phase	Trials
Phase 3	2
Phase 2/Phase 3	2
Phase 2	5

Clinical Trial Status

Clinical Trial Status for Perflutren
Clinical Trial Phase	Trials
Completed	13
Recruiting	5
Withdrawn	2

Clinical Trial Sponsors for Perflutren

Sponsor Name

Sponsor Name for Perflutren
Sponsor	Trials
National Cancer Institute (NCI)	6
Sidney Kimmel Cancer Center at Thomas Jefferson University	4
Thomas Jefferson University	3

Sponsor Type

Sponsor Type for Perflutren
Sponsor	Trials
Other	30
NIH	10
Industry	7

Perflutren: A Comprehensive Update on Clinical Trials, Market Analysis, and Projections

Last updated: January 1, 2025

Introduction to Perflutren

Perflutren, known by brand names such as Definity, Luminity, and Optison, is a diagnostic medication designed to enhance contrast during echocardiograms. It consists of lipid-coated microspheres filled with octafluoropropane (OFP) gas, which resonate when exposed to ultrasound waves, improving the visibility of the heart's inner structures[2].

Recent Clinical Trials and FDA Approval

In a significant development, the FDA approved Perflutren Lipid Microsphere (Definity) for use in pediatric patients with suboptimal echocardiograms. This approval was based on positive data from three pediatric clinical trials, including the Golding, Fine, and Kutty studies. These trials demonstrated the effectiveness of Perflutren in enhancing left ventricular opacification and improving the detection of wall motion abnormalities and ejection fraction determinations[1].

• Golding Study: Showed that left ventricular opacification with Perflutren was successful, with cumulative doses ranging from 6 µL/kg to 20 µL/kg. The study found improvements in detecting wall motion abnormalities and performing ejection fraction determinations in 70% and 80% of patients, respectively[1].
• Fine and Kutty Studies: Observed left ventricular opacification in all patients. The Kutty study specifically noted that wall motion and/or myocardial perfusion wall motion abnormalities were identified in 11.5% of patients during stress testing, with an improvement in the number of left ventricular segments visualized[1].

Pharmacokinetics and Pharmacodynamics

Recent studies have delved into the pharmacokinetics and pharmacodynamics of Perflutren. A study involving healthy male and female Chinese volunteers found that after intravenous infusion of 10 µL/kg of Perflutren, the drug was rapidly cleared from the body, primarily through the lungs in the expired air. The study highlighted that female subjects had slightly faster and more extensive excretion of Perflutren via the lungs compared to males[4].

• Blood Concentration: The study showed that the blood drug concentration of female subjects was lower than that of males, with differences in peak concentration, area under the curve (AUC), and other pharmacokinetic parameters[4].
• Doppler Signal Intensity: The change in blood drug concentration was closely related to the change in Doppler signal intensity, indicating the drug's rapid onset and clearance[4].

Market Analysis and Projections

The approval of Perflutren for pediatric use is expected to impact the broader market for ultrasound contrast agents and clinical trials.

Clinical Trials Market

The U.S. clinical trials market, which includes trials for new drugs, vaccines, and devices, is poised for significant growth. Valued at USD 25.81 billion in 2023, the market is projected to reach USD 41.57 billion by 2033. This growth is driven by the increasing demand for innovative healthcare solutions and the rigorous regulatory environment ensuring patient safety and data integrity[3].

Ultrasound Contrast Agents Market

The approval of Perflutren for pediatric patients expands its market potential. As a diagnostic tool, Perflutren enhances echocardiographic images, which is crucial in pediatric cardiology where clear imaging can be challenging. This expansion is likely to increase the adoption rate of Perflutren in clinical settings, contributing to the growth of the ultrasound contrast agents market.

Safety and Tolerability

Clinical trials and pharmacokinetic studies have consistently shown that Perflutren is well-tolerated by patients. The drug does not have pharmacologic action and is primarily cleared through the lungs, reducing the risk of adverse reactions. Studies have found no evidence of microvessel bleeding or significant differences in blood concentration curves between normal and chronic obstructive pulmonary disease (COPD) subjects[5].

Clinical Efficacy

Perflutren has demonstrated significant clinical efficacy in enhancing echocardiographic images. By improving the visibility of the left ventricular endocardial border, it aids in the diagnosis and management of cardiac conditions. The ability to detect wall motion abnormalities and perform accurate ejection fraction determinations is crucial for guiding patient care, especially in challenging pediatric cardiac cases[1].

Expert Insights

According to Kassa Darge, MD, PhD, radiologist-in-chief at Children’s Hospital of Philadelphia, "This approval offers a critical diagnostic tool for pediatric heart patients and their families. It will provide a valuable alternative to pediatric cardiologists trying to do imaging work up in challenging pediatric cardiac cases."[1]

Future Directions

As the demand for advanced diagnostic tools continues to grow, the market for ultrasound contrast agents like Perflutren is expected to expand. Ongoing research and clinical trials will further establish the safety and efficacy of Perflutren in various patient populations, potentially leading to additional approvals and broader clinical applications.

Key Takeaways

• FDA Approval: Perflutren Lipid Microsphere has been approved for use in pediatric patients with suboptimal echocardiograms.
• Clinical Trials: Positive data from three pediatric clinical trials supported the FDA approval.
• Pharmacokinetics: Perflutren is rapidly cleared through the lungs, with differences in excretion rates between males and females.
• Market Growth: The U.S. clinical trials market and the ultrasound contrast agents market are expected to grow significantly.
• Safety and Efficacy: Perflutren is well-tolerated and has demonstrated significant clinical efficacy in enhancing echocardiographic images.

FAQs

What is Perflutren used for?

Perflutren is used as an ultrasound contrast agent to improve the visibility of the heart's inner structures during echocardiograms.

What is the recent FDA approval for Perflutren?

The FDA has approved Perflutren Lipid Microsphere for use in pediatric patients with suboptimal echocardiograms.

How is Perflutren cleared from the body?

Perflutren is primarily cleared through the lungs in the expired air.

What are the key findings from the recent pharmacokinetic study?

The study found that female subjects had slightly faster and more extensive excretion of Perflutren via the lungs compared to males, and the drug's blood concentration was closely related to the Doppler signal intensity.

What is the projected growth of the U.S. clinical trials market?

The U.S. clinical trials market is projected to grow from USD 27.07 billion in 2024 to USD 41.57 billion by 2033.

Sources

1. FDA approves Perflutren Lipid Microsphere for pediatric patients with suboptimal echocardiograms. Contemporary Pediatrics.
2. Perflutren: Uses, Interactions, Mechanism of Action. DrugBank Online.
3. U.S. Clinical Trials Market Size Industry Analysis Report, 2033. BioSpace.
4. Pharmacokinetics and pharmacodynamics of perfluoropropane after intravenous administration of Definity in healthy Chinese volunteers. PubMed.
5. Perflutren lipid microsphere injectable suspension for cardiac ultrasound. Open Access Journals.