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DEFINITY · 4 trials · 7 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.
Correlation
ANOVA/Post-hoc comparisons
| 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). |
| 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® |
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 investigational small molecule being studied for use in cardiac disease, cardiac catheterization, and chronic exertional compartment syndrome. In cardiac applications, it is being evaluated to improve the accuracy of ejection fraction assessment. It is also being studied as a diagnostic tool for chronic exertional compartment syndrome.
DEFINITY is being developed by Lantheus Holdings, Inc., which trades under the ticker LNTH. The company is conducting clinical trials of DEFINITY in the United States across multiple indications, including cardiac disease and chronic exertional compartment syndrome.
DEFINITY is in Phase 3 clinical development for cardiac disease, based on completed trials NCT03571672 and NCT03719612. It has also completed Phase 2 trials for cardiac catheterization and chronic exertional compartment syndrome. DEFINITY is investigational and has not been reported as FDA approved.
DEFINITY has completed four clinical trials in the United States. These include NCT03571672 and NCT03719612, both Phase 3 studies in cardiac disease, NCT03243942, a Phase 2 study in cardiac catheterization, and NCT05247541, a Phase 2 study in chronic exertional compartment syndrome. All trials are completed.
No, DEFINITY is not the same as SHAPE. SHAPE appears in the title of a clinical trial, NCT05247541, which evaluates diagnosing compartment syndrome with SHAPE versus elastography. DEFINITY is the drug being studied in that trial, but SHAPE is a separate diagnostic method or technology.