Please assess the completion status of the following clinical trial:

Trial Title: SonoVue®-Enhanced Ultrasound (US) Versus Unenhanced US for Focal Liver Lesion Characterization

Study Design Characteristics:
- Allocation: None
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: DIAGNOSTIC
- Time Perspective: None
- Masking: NONE
- Phase: PHASE3
- Number of Arms: 1.0

Eligibility Criteria:
Inclusion Criteria:~* Male/female.~* Provides written Informed Consent and is willing to comply with protocol requirements.~* Is at least 18 years of age.~* Has at least 1 FLL (target lesion) requiring work-up for characterization. Target lesions may include those:~Incidentally detected, In subjects with chronic hepatitis or liver cirrhosis, In subjects with known history of malignancy.~* Is scheduled for surgical removal or biopsy of the target lesion from 24 hours to 30 days after the SonoVue® administration OR~* In case tissue biopsy is not indicated nor surgery planned, is scheduled for or has performed a CE-CT and/or CE-MRI of the target lesion from 30 days to 48 hours prior to or from 24 hours to 30 days after the administration of SonoVue®.~Exclusion Criteria:~* Has an acoustic window insufficient for adequate ultrasound examination of the liver.~* Has a FLL that cannot be identified with unenhanced ultrasound.~* Has received or is scheduled for antineoplastic chemotherapy or an invasive procedure in the time period between test procedures and truth standard assessments which may have modified the target lesion.~* Is receiving any other contrast medium, within the 48 hours before and up to 24 hours following the administration of SonoVue®.~* Has previously been enrolled in and completed this study.~* Known right to left cardiac shunt, bidirectional or transient.~* Has any known allergy to 1 or more of the ingredients of the investigational product (sulfur hexafluoride or to any components of SonoVue®).~* Has any contraindication to 1 of the planned imaging procedures (ultrasound, CT or MRI), e.g., implants, claustrophobia, inadequate medical conditions etc.~* Has received an investigational compound within 30 days before admission into this study.~* Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post-dose follow-up examinations.~* Is determined by the Investigator that the subject is clinically unsuitable for the study.~* Is a pregnant or lactating female. Exclude the possibility of pregnancy by:~testing on site at the institution serum βHCG within 24 hours prior to the start of SonoVue® administration, surgical history (e.g., tubal ligation or hysterectomy), post menopausal with a minimum 1 year without menses.

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Patients who received SonoVue (Type: OTHER): Patients with at least one target lesions requiring work-up for characterization to undergo~* Unenhanced ultrasound of the target lesion (UE-US): gray scale and Doppler (color or power imaging) ultrasound investigations of the target lesion using commercially available ultrasound equipment and standard techniques (B-mode or Harmonic imaging) to study the anatomy of the target lesion and surrounding parenchyma;~* SonoVue-enhanced ultrasound of the target lesion (CE-US):procedures described in protocol Section 7.5.1.2, to study the lesion vascularity in comparison to the surrounding parenchyma; and~* Truth standard~2.4 mL of sulfur hexafluoride microbubbles (SonoVue®) will be administered as a bolus injection in a peripheral vein.

Based on this trial design, predict the completion outcome and termination type (if applicable).

Answer: outcome: complete