Ultrasonographic characterization of small nodules in cirrhotic patients using contrast media through splancnic infusion - ND

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-005364-27-IT

Enrollment

Registered

2007-11-23

Start date

2007-09-25

Completion date

Unknown

Last updated

2022-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hepatic cirrhosis MedDRA version: 9.1 Level: LLT Classification code 10019641 Term: Hepatic cirrhosis

Interventions

Trade Name: SONOVUE*1FL 8MCG+1SIR 5ML+ADAT Pharmaceutical Form: Powder and solvent for suspension for injection INN or Proposed INN: Sulfur hexafluoride Concentration unit: µg/ml microgram(s)/millilit

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age> 18 years Hepatic cirrhosis Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Cardiopaty

Design outcomes

Primary

Measure	Time frame
Secondary Objective: Not declared;Main Objective: Primary endpoint of this study is the identification of contrast enhanced ultrasound criteria to predict the malignant evolution of hepatic lesions in cirrhotic patients, when lesions have not malignant characteristics at basal ultrasound examination and conventional contrasted enhanced techniques (CT and/or MRI).;Primary end point(s): Primary endpoint of this study is the identification of contrast enhanced ultrasound criteria to predict the malignant evolution of hepatic lesions in cirrhotic patients, when lesions have not malignant characteristics at basal ultrasound examination and conventional contrasted enhanced techniques (CT and/or MRI).	—

Measure

Time frame

Secondary Objective: Not declared;Main Objective: Primary endpoint of this study is the identification of contrast enhanced ultrasound criteria to predict the malignant evolution of hepatic lesions in cirrhotic patients, when lesions have not malignant characteristics at basal ultrasound examination and conventional contrasted enhanced techniques (CT and/or MRI).;Primary end point(s): Primary endpoint of this study is the identification of contrast enhanced ultrasound criteria to predict the malignant evolution of hepatic lesions in cirrhotic patients, when lesions have not malignant characteristics at basal ultrasound examination and conventional contrasted enhanced techniques (CT and/or MRI).

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Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026