Lantheus MI Canada, Inc.

Primary objective: To evaluate the ability of DEFINITY contrast-enhanced ultrasound imaging to provide additional diagnostic information to patients undergoing renal diagnostic ultrasound examinations. Secondary objectives: To confirm the sensitivity and specificity of DEFINITY contrast-enhanced ultrasound in identifying benign and malignant focal renal lesions using final diagnostic results from a comprehensive set of real-world standards; to evaluate the ability of DEFINITY contrast-enhanced ultrasound to obtain a specific diagnosis, the diagnostic reliability, compared with ultrasound after placebo administration; and to evaluate the safety of DEFINITY administration.

Primary objective: To evaluate the pharmacokinetic characteristics of DEFINITY in healthy Chinese volunteers by monitoring the kinetics of the PFP component after intravenous injection of the maximum recommended clinical dose (10 μL/kg) of DEFINITY. Secondary objectives: To evaluate the safety of DEFINITY in healthy Chinese volunteers; To qualitatively compare the pharmacokinetic characteristics of DEFINITY in healthy Chinese volunteers with those in the DMP115-905 study; To evaluate the Doppler intensity characteristics of blood microbubbles during Doppler ultrasound examination.

Primary objective: To evaluate the ability of DEFINITY CEUS imaging to provide additional diagnostic information to patients undergoing diagnostic liver ultrasound examinations. Secondary objectives: To confirm the sensitivity and specificity of DEFINITY CEUS in identifying benign and malignant focal liver lesions using final diagnostic results from a comprehensive set of real-world standards; to evaluate the ability of DEFINITY CEUS to obtain specific diagnoses, diagnostic reliability compared with ultrasound after placebo administration; and to evaluate the safety of DEFINITY administration.