Pilot study to optimise the use and to evaluate the diagnostic value of intraoperative contrast-enhanced 3D-ultrasound with SonoVue® for imaging of intracranial tumors

Phase 2

• Conditions: Brain tumor

• Registration Number: DRKS00000769
• Lead Sponsor: niversitätsklinikum Leipzig

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03-25
• Study Completion: 2013-12-23
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

–signed informed consent
–age = 18 years
– Patients with an intracranial tumor and planned operation as well as expected echoic behaviour of the tumor.
–:Ensured tumor in cranial MRi
I) Astrocytic tumors
II) Oligodendroglioma
III) Ependymoma
IV) Plexus choroidea Tumors
V) Pineal Tumors
VI) Embryonal Tumors
VII)Meningeal Tumors
VIII) Lymphoma
IX) Tumors of the Sella
X) Metastasis

Exclusion Criteria

–ASA 4 classificated patient
–Acute coronary syndrome
–Acute angina pectoris
–Disheveled Hypertension
–Acute heart failure
–NYHA III-IV
–Pulmonary hypertension
–Left-right reverals
–Heart intervention briefer 2 weeks
–Endocarditis
–Need of dialysis
–Hepatic insufficient
–Acute Sepsis
–ARDS (Acute Respiratory Distress Syndrom)
–Acute respiratory distress
–Allergy for SonoVue®
–Allergy for coupling agent
–Participation in other clinical trails
–Pregnant or nursing women
–No compliante patient
–Actual drug abuse
–Fertile women with no appropriate contraception or no longer than two years after the last menstruation

Study & Design

• Study Type: interventional
• Study Design: Not specified