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A Phase III, Open-Label, Multicenter Trial to Evaluate Ejection Fraction, End-Diastolic and End-Systolic Volumes, by Unenhanced and DEFINITY-Enhanced 2D-Echo and Magnetic Resonance Imaging

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Trial Profile

A Phase III, Open-Label, Multicenter Trial to Evaluate Ejection Fraction, End-Diastolic and End-Systolic Volumes, by Unenhanced and DEFINITY-Enhanced 2D-Echo and Magnetic Resonance Imaging

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 22 Dec 2020

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At a glance

  • Drugs Perflutren (Primary)
  • Indications Cardiovascular disorders
  • Focus Diagnostic use; Registrational
  • Acronyms BENEFIT 1 LVEF; BENEFIT1
  • Sponsors Lantheus Medical Imaging

Most Recent Events

  • 03 Feb 2020 According to a Lantheus Holdings media release, BENEFIT 1 is one of the two Phase 3 studies (BENEFIT 1 and BENEFIT 2) to evaluate LVEF measurement accuracy and reproducibility of DEFINITY contrast-enhanced and unenhanced echocardiography as compared to non-contrast cardiac magnetic resonance imaging (CMRI) used as the truth standard.When the data from BENEFIT 2 are available, the company will compile the data sets to analyze the full results of the trials.
  • 03 Feb 2020 According to a Lantheus Holdings media release, although the endpoints for BENEFIT 1 were not met, the company will continue to analyze the BENEFIT 1 data.
  • 03 Feb 2020 Primary endpoint (Demonstrate improvements in left ventricular ejection fraction measurement accuracy from unenhanced 2D echo imaging to imaging with DEFINITY contrast-enhanced 2D echo using cardiac magnetic resonance imaging as the truth standard) has not been met, according to a Lantheus Holdings media release.

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