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Label indication DEFINITY RT is indicated, after activation, for use in adult and pediatric patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border. FDA label
Also known as Definity RT, perflutren lipid microsphere, Perflutren Lipid Microsphere injectable suspension
Definity · 5 trials · 11 indications
Demonstrate improvement in accuracy in left ventricular ejection fraction (LVEF) assessment using DEFINITY® contrast-enhanced over unenhanced echocardiography by comparing LVEF percentage differences from CMR measured by 3 independent blinded image readers.
Evaluate the ability of SHAPE with microbubbles and SWE to accurately diagnose chronic exertional compartment syndrome (CECS) in percent using ROC analysis.
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The number of participants who completed trial procedures among at least 80 percent of patients, among patients with recurrent or metastatic head and neck squamous cell carcinoma.
| Arm | Type | Description |
|---|---|---|
| DEFINITY® | EXPERIMENTAL | Each patient will undergo an unenhanced ultrasound examination and a DEFINITY® contrast-enhanced ultrasound |
| DEFINITY | EXPERIMENTAL | Each patient will undergo an unenhanced ultrasound examination and a DEFINITY contrast-enhanced ultrasound |
| Healthy Participants | ACTIVE_COMPARATOR | - |
| Study participants | EXPERIMENTAL | - |
| Definity for pressure measurements | EXPERIMENTAL | 2 vials of activated Definity mixed with 50 ml saline. As per manufacturer's recommendation the infusion rate may vary between 4-10 ml/min (to provide diagnostic intracardiac contrast visibility). |
| Arm 1: Pembro + Ultrasound-Induced Microbubble Cavitation | EXPERIMENTAL | Treatment will be administered on an outpatient basis. 200 mg Pembrolizumab + 3 mL Definity infusions will be administered by nurses at Thomas Jefferson University every 3 weeks for up to 3 cycles. The first cycle will take 60 minutes, while the subsequent infusions should take half an hour to complete. |
| Name | Type | Description |
|---|---|---|
| DEFINITY® | DRUG | All subjects will receive a single dose of DEFINITY® |
| DEFINITY | DRUG | All subjects will receive a single dose of DEFINITY® |
| Pembrolizumab | DRUG | Pembrolizumab will be administered intravenously at a dose of 200 mg every 3 weeks for up to 3 cycles |
| Ultrasound-Induced Microbubble Cavitation | DEVICE | Therapeutic Ultrasound will be applied to the tumor site during and following the Definity infusion to induce microbubble cavitation using modified ultrasound parameters. |
Inclusion Criteria: 1. Men and women ≥ 18 years of age in sinus rhythm 2. Able to communicate effectively with trial personnel 3. LVEF measurements obtained via 2D Echo with or without contrast obtained within 6 months prior to enrollment (Day 0) 4. Has provided signed informed consent after receiv...
Definity is an ultrasound contrast agent studied for cardiac and other imaging applications. Its listed indications include cardiac catheterization, cardiac disease, chronic exertional compartment syndrome, and head and neck cancer. It is also known as DEFINITY and is developed by Lantheus Holdings, Inc.
Definity is developed by Lantheus Holdings, Inc., which trades under the ticker LNTH. The company is the sponsor behind the clinical programs evaluating the agent across cardiac imaging and other indications.
Definity has been studied across Phase 1, Phase 2, and Phase 3 clinical trials. Its listed development stage is Phase 2, with one active trial and completed studies in cardiac disease and chronic exertional compartment syndrome. It remains an investigational agent in these research settings.
Definity has been evaluated in trials including NCT07501650, a recruiting Phase 1 study of pembrolizumab plus ultrasound-induced microbubble cavitation in head and neck cancer, and NCT05247541, a completed Phase 2 study diagnosing compartment syndrome. Completed Phase 3 studies NCT03719612 and NCT03571672 assessed ejection fraction accuracy in cardiac disease.
Across the listed Definity studies, total enrollment is 313 participants. The largest studies are the completed Phase 3 cardiac disease trials NCT03719612 with 160 participants and NCT03571672 with 153 participants. The Phase 1 head and neck cancer study NCT07501650 plans to enroll 6 participants.